ClearanceBrief
Company ยท US

Coulter Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2000. Name variants (Inc, Corp, punctuation) are merged.

51510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GKZCounter, Differential Cell23
JPKMixture, Hematology Quality Control5
GKLCounter, Cell, Automated (Particle Counter)3
CIGDiazo Colorimetry, Bilirubin2
KHSEnzymatic, Carbon-Dioxide2
CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen1
CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus1
CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes1
CGXAlkaline Picrate, Colorimetry, Creatinine1
CIXBromcresol Green Dye-Binding, Albumin1
CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes1
CJYAzo Dye, Calcium1
GGLControl, White-Cell1
GKHApparatus, Automated Blood Cell Diluting1
JFJCatalytic Methods, Amylase1
JGJPhotometric Method, Magnesium1
JIYPhotometric Method, Iron (Non-Heme)1
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use1
JQBKinetic Method, Gamma-Glutamyl Transpeptidase1
JZGSystem, Test, Beta-2-Microglobulin Immunological1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Apr 20, 2000K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
Coulter Corp.
GKZ
May 11, 1999K991070COULTER Z2 ANALYZER
Coulter Corp.
GKL
Apr 26, 1999K990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
Coulter Corp.
GKZ
Apr 13, 1999K990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
Coulter Corp.
GKZ
Apr 1, 1999K990352COULTER AC T DIFF 2 ANALYZER
Coulter Corp.
GKZ
Mar 16, 1999K984216IMMUNO-TROL CONTROL CELLS
Coulter Corp.
JPK
Nov 9, 1998K982167CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
Coulter Corp.
GKZ
Nov 5, 1998K982166CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
Coulter Corp.
GKZ
Sep 24, 1998K982172CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL
Coulter Corp.
GKZ
Oct 29, 1997K973634COULTER AC.T DIFF ANALYZER
Coulter Corp.
GKZ
Jun 30, 1997K971469COULTER ACT TRON CELL CONTROL
Coulter Corp.
JPK
Mar 6, 1997K964988COULTER AC.T SERIES ANALYZER
Coulter Corp.
GKZ
Jan 22, 1997K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
Coulter Corp.
GKZ
Jan 6, 1997K962768CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL
Coulter Corp.
GKZ
Jan 6, 1997K962305CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL
Coulter Corp.
GKZ
Dec 23, 1996K964618CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1
Coulter Corp.
GKZ
Oct 30, 1996K962988COULTER GEN-S SYSTEM
Coulter Corp.
GKL
Jul 22, 1996K961278COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
Coulter Corp.
GKZ
Feb 29, 1996K954688FLOW-COUNT COULTER FLUOROSPHERES
Coulter Corp.
GKZ
Feb 8, 1996K955334COULTER LINEARITY CONTROL
Coulter Corp.
JPK
Jan 30, 1996K9550164C PLUS COULTER CELL CONTROL
Coulter Corp.
JPK
Oct 6, 1995K952308COULTER Z 1
Coulter Corp.
GKL
Aug 25, 1995K950742CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
Coulter Corp.
GKZ
Jul 20, 1995K950949COULTER MH025A
Coulter Corp.
GKZ
Mar 6, 1995K943967ONYX
Coulter Corp.
GKZ
Dec 8, 1994K944751COULTER FLOW SET
Coulter Corp.
JPK
Mar 11, 1994K935953COULTER MULTI Q PREP
Coulter Corp.
GKH
Aug 23, 1993K932030COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY
Coulter Corp.
GKZ
Aug 23, 1993K930913COULTER MH015 (DIFFERENTIAL CELL COUNTER)
Coulter Corp.
GKZ
Jul 6, 1993K926124CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
Coulter Corp.
GKZ
Jan 21, 1993K925344COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
Coulter Corp.
GKZ
Sep 23, 1992K923421COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
Coulter Corp.
JZG
Nov 27, 1991K914486COULTER CARBON DIOXIDE REAGENT
Coulter Corp.
KHS
Jul 31, 1990K902174COULTER HDL - CHOLESTEROL REAGENT
Coulter Corp.
LBR
Jun 28, 1990K902172COULTER CREATININE REAGENT
Coulter Corp.
CGX
Jun 12, 1990K902229COULTER CARBON DIOXIDE REAGENT
Coulter Corp.
KHS
Jun 12, 1990K902199COULTER DIRECT BILIRUBIN
Coulter Corp.
CIG
Jun 12, 1990K902175COULTER UREA NITROGEN REAGENT
Coulter Corp.
CDQ
Jun 12, 1990K902173COULTER SERUM IRON/UIBC REAGENT
Coulter Corp.
JIY
May 30, 1990K901268COULTER ALBUMIN REAGENT
Coulter Corp.
CIX
May 23, 1990K901267COULTER CK (CREATINE KINASE) REAGENT
Coulter Corp.
CGS
Apr 25, 1990K901266COULTER TOTAL BILIRUBIN REAGENT
Coulter Corp.
CIG
Apr 16, 1990K901264COULTER GAMMA-GT (GGT) REAGENT
Coulter Corp.
JQB
Apr 3, 1990K900231COULTER CALCIUM REAGENT
Coulter Corp.
CJY
Apr 3, 1990K900230COULTER AMYLASE REAGENT
Coulter Corp.
JFJ
Mar 30, 1990K896873COULTER JT3
Coulter Corp.
GKZ
Mar 29, 1990K901265COULTER MAGNESIUM REAGENT
Coulter Corp.
JGJ
Feb 8, 1990K900216COULTER ALP (ALK PHOS) REAGENT
Coulter Corp.
CJE
Feb 8, 1990K900215COULTER PHOSPHORUS REAGENT
Coulter Corp.
CEO
Sep 13, 1989K894651COULTER POSITIVE CONTROL CELLS
Coulter Corp.
GGL

Newest 50 of 51.

Latest recalls

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