ClearanceBrief
Company ยท US

Pointe Scientific, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2007. Name variants (Inc, Corp, punctuation) are merged.

74510(k) clearances (0 in 12 months)
81recalls (0 in 12 months)
80recalls that name a 510(k)

Product codes

CodeDeviceRecords
CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes20
CFRHexokinase, Glucose19
CKANadh Oxidation/Nad Reduction, Alt/Sgpt10
JIYPhotometric Method, Iron (Non-Heme)10
JIXCalibrator, Multi-Analyte Mixture8
LBRLdl & Vldl Precipitation, Hdl8
CCH6
CICCresolphthalein Complexone, Calcium6
CIGDiazo Colorimetry, Bilirubin6
CGXAlkaline Picrate, Colorimetry, Creatinine4
CITNadh Oxidation/Nad Reduction, Ast/Sgot4
JFJCatalytic Methods, Amylase4
KNKAcid, Uric, Uricase (Colorimetric)4
LCPAssay, Glycosylated Hemoglobin4
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides3
CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase3
CGAGlucose Oxidase, Glucose3
KHSEnzymatic, Carbon-Dioxide3
CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen2
CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 4, 2007K070757MICROPROTEIN REAGENT SET
Pointe Scientific, Inc.,
JGP
Jul 13, 2007K062118POINTE 360
Pointe Scientific, Inc.,
CFR
Apr 30, 2007K070251CARBON DIOXIDE LIQUID STABLE REAGENT
Pointe Scientific, Inc.,
KHS
Apr 13, 2007K070207MULTI-ANALYTE CHEMISTRY CALIBRATOR
Pointe Scientific, Inc.,
JIX
Apr 11, 2007K070504AMMONIA/ALCOHOL CONTROL SET
Pointe Scientific, Inc.,
JJY
Mar 28, 2007K061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
Pointe Scientific, Inc.,
MSJ
Oct 7, 2005K051646ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
Pointe Scientific, Inc.,
JGS
Jun 2, 2004K040391TOTAL BILIRUBIN REAGENT SET
Pointe Scientific, Inc.,
CIG
Aug 6, 2003K031539HEMOGLOBIN A1C REAGENT SET
Pointe Scientific, Inc.,
LCP
Apr 28, 2003K023860MICROALBUMIN REAGENT SET AND CALIBRATORS
Pointe Scientific, Inc.,
DDZ
Mar 31, 2003K024006G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
Pointe Scientific, Inc.,
JBF
Dec 23, 2002K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
Pointe Scientific, Inc.,
CIJ
Nov 20, 2000K002199MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
Pointe Scientific, Inc.,
CFR
Oct 13, 2000K002651C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
Pointe Scientific, Inc.,
DCK
Dec 21, 1999K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
Pointe Scientific, Inc.,
LCP
Aug 5, 1999K992002AUTOHDL CHOLESTEROL REAGENT SET
Pointe Scientific, Inc.,
LBR
Jul 22, 1998K981978AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
Pointe Scientific, Inc.,
MRR
Oct 22, 1997K973588LIQUID ALKALINE PHOSHATASE REAGENT SET
Pointe Scientific, Inc.,
CJE
Oct 10, 1997K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
Pointe Scientific, Inc.,
JQB
Oct 8, 1997K973589LIQUID LDH-L REAGENT SET
Pointe Scientific, Inc.,
CFJ
Sep 25, 1997K972725ALCOHOL REAGENT SET
Pointe Scientific, Inc.,
DIC
Jul 22, 1997K971754LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
Pointe Scientific, Inc.,
CFR
Jul 20, 1997K972671BUN (LIQUID) REAGENT SET
Pointe Scientific, Inc.,
CDQ
May 23, 1997K970933AUTO HDL CHOLESTEROL CALIBRATOR
Pointe Scientific, Inc.,
JIS
Apr 21, 1997K970781LIQUID GLUCOSE (OXIDASE) REAGENT SET
Pointe Scientific, Inc.,
CGA
Mar 11, 1997K970560URIC ACID (LIQUID) REAGENT SET
Pointe Scientific, Inc.,
KNK
Nov 18, 1996K961588TOTAL IRON (NITRO-PAPS) REAGENT SET
Pointe Scientific, Inc.,
JIY
Jun 3, 1996K961431LACTATE DEHYDROGENASE REAGENT SET
Pointe Scientific, Inc.,
CFJ
Aug 1, 1994K940735LIQUID AMYLASE (CNPG3) REAGENT SET
Pointe Scientific, Inc.,
CIJ
May 3, 1994K941287LIQUID ALT(SGPT) REAGENT SET
Pointe Scientific, Inc.,
CKA
May 2, 1994K941132LIQUID AST (SGOT)REAGENT SET
Pointe Scientific, Inc.,
CIT
Jan 11, 1994K935463CREATINE KINASE-MB (CK-MB) REAGENT SET
Pointe Scientific, Inc.,
CGS
Jul 19, 1993K930475LIQUID AMYLASE REAGENT SET
Pointe Scientific, Inc.,
JFJ
Mar 29, 1993K930660CREATINE KINASE (CK) REAGENT SET
Pointe Scientific, Inc.,
CGS
Jul 28, 1992K920449POINTE 750 GLYCOMETER
Pointe Scientific, Inc.,
LCP
May 13, 1992K921625CALCIUM-ARSENAZO III REAGENT SET
Pointe Scientific, Inc.,
CIC
Dec 4, 1991K914873DIAZO COLORIMETRY, BILIRUBIN
Pointe Scientific, Inc.,
CIG
Apr 30, 1991K910158AMYLASE
Pointe Scientific, Inc.,
JFJ
Feb 23, 1990K896812CARBON DIOXIDE REAGENT
Pointe Scientific, Inc.,
KHS
Feb 1, 1990K896590CARBON DIOXIDE REAGENT
Pointe Scientific, Inc.,
KHS
Apr 10, 1989K891117HDL CHOLESTEROL REAGENT
Pointe Scientific, Inc.,
LBR
Dec 4, 1987K874131CRESOLPHTHALEIN COMPLEXONE, CALCIUM
Pointe Scientific, Inc.,
CIC
Jan 21, 1987K864882FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY
Pointe Scientific, Inc.,
JIY
Jan 21, 1987K864464PSI AMYLASE REAGENT
Pointe Scientific, Inc.,
JFJ
Dec 16, 1986K863832NAPHTHYL PHOSPHATE, ACID PHOSPHATASE
Pointe Scientific, Inc.,
JFH
Jul 22, 1986K862033TRIGLYCERIDES
Pointe Scientific, Inc.,
CDT
May 16, 1986K860572GLYCOHEMOGLOBIN, IN-VITRO DIAGNOSTIC REAGENT SET
Pointe Scientific, Inc.,
LCP
Feb 21, 1986K860257DIRECT BILIRUBIN
Pointe Scientific, Inc.,
CIG
Sep 16, 1985K853592MAGNESIUM
Pointe Scientific, Inc.,
JGJ
Aug 21, 1985K852169CHLORIDE REAGENT
Pointe Scientific, Inc.,
CHJ

Newest 50 of 74.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 16, 2015Pointe Scientific, Inc.
Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90
Terminated
CGXK830556
Sep 14, 2015Pointe Scientific, Inc.
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and
Terminated
LBRK992002
Aug 31, 2015Pointe Scientific, Inc.
Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored
Terminated
JBFK024006
Mar 10, 2010Pointe Scientific, Inc.
Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalo
Terminated
CICK822469
Mar 10, 2010Pointe Scientific, Inc.
Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalo
Terminated
CICK822469
Mar 10, 2010Pointe Scientific, Inc.
Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging, Catalog # HC
Terminated
CICK822469
Mar 9, 2010Pointe Scientific, Inc.
Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250. For th
Terminated
CGXK830556
Mar 9, 2010Pointe Scientific, Inc.
Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-5
Terminated
CGXK830556
Mar 5, 2010Pointe Scientific, Inc.
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI., Catalog # HB936-1250.
Terminated
CIGK040391
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vi
Terminated
KNKK970560
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzer
Terminated
KNKK970560
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: 8HI904-R2-100.
Terminated
JIYK864882
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-COL-15, 7-I7504-COL-5, 7-I7504-COL-60, 8-I7504-COL-15, 8-I7504-COL-60 and 3-I7504-COL. Clinical c
Terminated
JIYK864882
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI., Catalog #s: 7-I7504-BUF-1000, 7-I7504-BUF-120, 7-I7504-BUF-75, 8-I7504-BUF-500 and 3-I7504-BUF. Clinical chemistry
Terminated
JIYK864882
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R2. Clinical chemistry reagent for the quantit
Terminated
JIYK864882
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R1. Clinical chemistry reagent for the quant
Terminated
JIYK864882
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: HI704-300, HI904-1200, HI904-498, HI904-600, HI904-SAM
Terminated
JIYK864882
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7505-120, I7505-500. Clinical chemistry reagent for the q
Terminated
JIYK864882
Mar 2, 2010Pointe Scientific, Inc.
Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7504-60, I7504-400, I7504-SAM, 10
Terminated
JIYK864882
Feb 25, 2010Pointe Scientific, Inc.
Liquid HDL (PEG) Cholesterol Reagent, Pointe Scientific, Inc, Canton, MI; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry). For the quantitative determination of high density lipopr
Terminated
LBRK812574
Feb 25, 2010Pointe Scientific, Inc.
Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set,
Terminated
LBRK812574
Nov 4, 2009Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and
Terminated
CFRK971754
Apr 27, 2009Pointe Scientific, Inc.
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-8
Terminated
LBRK992002
Apr 27, 2009Pointe Scientific, Inc.
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-8
Terminated
LBRK992002
Apr 17, 2009Pointe Scientific, Inc.
Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bil
Terminated
CIGK040391
Mar 12, 2009Pointe Scientific, Inc.
Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # G7519-1L, G7519-500 and G7519-SAM. 2MM Diagnostics Glucose Oxidase Re
Terminated
CGAK810674
Oct 31, 2008Pointe Scientific, Inc.
Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)
Terminated
CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
Terminated
CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG920-1200, HG920-2500 and 12-HG920-144. (Clinical chemistry)
Terminated
CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (Clinical chemistry)
Terminated
CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry)
Terminated
CFRK002199
Oct 31, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R1. (Clinical chemistry)
Terminated
CFRK002199
Oct 22, 2008Pointe Scientific, Inc.
AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the quantitative determination of aspartate amoinotransferase in human serum
Terminated
CITK941132
Oct 22, 2008Pointe Scientific, Inc.
Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate
Terminated
CITK941132
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 305 ml, Catalog no. HA 726-305, in vitro diagnostic, Pointe Scientific, Inc.; C
Terminated
CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc
Terminated
CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc
Terminated
CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated
CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated
CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated
CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated
CKAK941287
May 22, 2008Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Ca
Terminated
CKAK941287
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alkaline Phosphatase Reagent Set; Catalog No. A7516-150-SAM, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Sold by Pointe Scientific, Inc
Terminated
CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Sold b
Terminated
CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Alk Phos R1 (also labeled as Alkaline Phosphatase R1) Reagent, Catalog Nos. 7-A7516-R1-120, 7-A7516-R1-500 and 8-A7516-R1-120, In vitro diagnostic, 50 mL, 120 mL , 2 L and 500 mL containers, Sold by
Terminated
CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alk Phos R2 Reagent, Catalog No. 3-A7516-R2, In vitro diagnostic, Sold by Pointe Scientific
Terminated
CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alk Phos R1 Reagent, Catalog No. 3-A7516-R1, In vitro diagnostic, Sold by Pointe Scientific.
Terminated
CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alk Phos Reagent, Catalog No. 3-A7516-L, In vitro diagnostic, Sold by Pointe Scientific.
Terminated
CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alkaline Phosphatase (R2) Reagent Set, Catalog No.: H A416-R2, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum, Manufactured by Pointe Scientific, Inc
Terminated
CJEK973588
Mar 27, 2008Pointe Scientific, Inc.
Liquid Alkaline Phosphatase Reagent Set, Catalog Nos. A7516-150, A7516-450, A7516-625, HA916-302 and HA916-492, In vitro diagnostic; for the quantitative determination of alkaline phosphatase in serum
Terminated
CJEK973588

Newest 50 of 81.

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