ClearanceBrief
Company ยท US

Isolab, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1996. Name variants (Inc, Corp, punctuation) are merged.

44510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
LCPAssay, Glycosylated Hemoglobin7
GHMTest, Sickle Cell4
JCMControl, Hemoglobin, Abnormal4
DFTIgm, Antigen, Antiserum, Control2
JBDSystem, Analysis, Electrophoretic Hemoglobin2
LGLAssay, Bart'S, Hemoglobin2
CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes1
CKANadh Oxidation/Nad Reduction, Alt/Sgpt1
DFITotal Spinal-Fluid, Antigen, Antiserum, Control1
GDXScalpel, One-Piece1
GGMControl, Hemoglobin1
GIQHemoglobin S1
GKAAbnormal Hemoglobin Quantitation1
GQOAntisera, Cf, Herpesvirus Hominis 1,21
JHFColorimetric Method, Lecithin/Sphingomyelin Ratio1
JIAEnzymatic Methods, Galactose1
JJTEnzyme Controls (Assayed And Unassayed)1
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1
JJYMulti-Analyte Controls, All Kinds (Assayed)1
JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 18, 1996K951014ISOLAB'S T4 TEST KIT
Isolab, Inc.
KLI
Feb 1, 1996K950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
Isolab, Inc.
JIA
Jan 26, 1996K943547PHENYLALANINE TEST KIT
Isolab, Inc.
JNB
Sep 21, 1995K950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
Isolab, Inc.
JJT
Sep 5, 1995K950415FLUOROSCAN NEONATAL
Isolab, Inc.
KHO
Jan 20, 1995K942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
Isolab, Inc.
GIQ
Jan 20, 1995K942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
Isolab, Inc.
JCM
Nov 17, 1994K944185ISOSCAN
Isolab, Inc.
JQT
Apr 26, 1994K934013RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT
Isolab, Inc.
CIN
Jan 27, 1994K923153HEMOCARD, HEMOGLOBIN C ASSAY
Isolab, Inc.
MLL
May 11, 1993K931234HEMOCARD CONTROL HB-AA, AE, FAA, FAE
Isolab, Inc.
JCM
Apr 8, 1993K930070HEMOCARD HEMOGLOBIN E
Isolab, Inc.
CKA
Dec 1, 1992K924173HEMOCARD(TM) CONTROL
Isolab, Inc.
JCM
Nov 17, 1992K921681CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
Isolab, Inc.
GGM
Oct 9, 1991K911981HEMOCARD HEMOGLOBIN S
Isolab, Inc.
GHM
Apr 15, 1991K910430HEMOCARD-AS
Isolab, Inc.
GHM
Mar 11, 1991K910431HEMOCARD CONTROL
Isolab, Inc.
JCM
Jan 15, 1991K905513GLYC-AFFIN(TM)-GA
Isolab, Inc.
LCP
Dec 26, 1990K904814GLYC-AFFIN GP
Isolab, Inc.
LCP
Dec 7, 1990K902740LDL-DIRECT CONTROLS
Isolab, Inc.
JJY
Apr 12, 1990K901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
Isolab, Inc.
DFT
Mar 15, 1989K883411PG-NUMERIC(TM)
Isolab, Inc.
JHF
Nov 22, 1988K880673GHB SAMPLE PAPER
Isolab, Inc.
LCP
Apr 5, 1988K873428GLYCO-PROBE GSP
Isolab, Inc.
LCP
Aug 26, 1986K862638VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
Isolab, Inc.
LJC
May 20, 1986K854712VISIBLE-HERPES TM TEST SYSTEM
Isolab, Inc.
GQO
Nov 30, 1984K843122RESOLVE-CSF
Isolab, Inc.
DFI
Sep 9, 1984K842152SICKLING HEMOGLOBIN CONTROLS, NORMAL
Isolab, Inc.
GHM
Apr 4, 1984K841170SICKLE HB ASSAY
Isolab, Inc.
GHM
Feb 4, 1984K840011RESOLVE-HB
Isolab, Inc.
GKA
Mar 24, 1983K830606QUIK-SEP IGM ISOLATION SYSTEM
Isolab, Inc.
DFT
Dec 3, 1982K822867GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY
Isolab, Inc.
LCP
Jun 25, 1982K820630QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL
Isolab, Inc.
JPC
Sep 1, 1981K812318LIPO-SEP CHOLESTEROL AUDIT SYSTEM
Isolab, Inc.
May 29, 1981K810976ALPHA-THAL SCREEN TM CONTROL
Isolab, Inc.
LGL
Apr 23, 1981K810919HEMOGLOBIN ELECTROPHORESIS CONTROL
Isolab, Inc.
JBD
Jan 16, 1981K801771ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
Isolab, Inc.
LGL
Dec 22, 1980K802997HDL-CHOLESTEROL CONTROL SERUM
Isolab, Inc.
JJX
Jul 21, 1980K801410HEMOHLOBIN A2 CONTROL-LYOPHILIZED
Isolab, Inc.
JPD
Apr 29, 1980K800794FAST HEMOGLOBIN CONTROL-LYOPHILIZED
Isolab, Inc.
LCP
Jul 17, 1979K791143SICKLE-CELL F TEST
Isolab, Inc.
KQI
Nov 7, 1978K781851HEMOGLOBIN, TESTING SYSTEM
Isolab, Inc.
LCP
Jul 27, 1978K780998SCALPEL
Isolab, Inc.
GDX
Oct 7, 1977K771649HEMOGLOBIN A2 TESTING SYSTEM
Isolab, Inc.
JBD

Latest recalls

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