Medical Device Manufacturer · US , Hialeah , FL

Coulter Corp.

51 submissions · 51 cleared · Since 1989
51
Total
51
Cleared
0
Denied

Coulter Corp. — FDA 510(k) Submissions

Coulter Corp. has submitted 51 FDA 510(k) premarket notifications since 1989, of which 51 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, Mixture, Hematology Quality Control, Counter, Cell, Automated (particle Counter), Enzymatic, Carbon-dioxide, Diazo Colorimetry, Bilirubin . Use the specialty filter in the sidebar to narrow results.

51 devices
1–25 of 51
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
K993356 · GKZ Counter, Differential Cell · Hematology
Apr 2000 197d
COULTER Z2 ANALYZER
K991070 · GKL Counter, Cell, Automated... · Hematology
May 1999 41d
RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
K990327 · GKZ Counter, Differential Cell · Hematology
Apr 1999 83d
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
K990172 · GKZ Counter, Differential Cell · Hematology
Apr 1999 84d
COULTER AC T DIFF 2 ANALYZER
K990352 · GKZ Counter, Differential Cell · Hematology
Apr 1999 55d
IMMUNO-TROL CONTROL CELLS
K984216 · JPK Mixture, Hematology... · Hematology
Mar 1999 112d
CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
K982167 · GKZ Counter, Differential Cell · Hematology
Nov 1998 143d
CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
K982166 · GKZ Counter, Differential Cell · Hematology
Nov 1998 139d
CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL
K982172 · GKZ Counter, Differential Cell · Hematology
Sep 1998 97d
COULTER AC.T DIFF ANALYZER
K973634 · GKZ Counter, Differential Cell · Hematology
Oct 1997 35d
COULTER ACT TRON CELL CONTROL
K971469 · JPK Mixture, Hematology... · Hematology
Jun 1997 69d
COULTER AC.T SERIES ANALYZER
K964988 · GKZ Counter, Differential Cell · Hematology
Mar 1997 83d
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
K963263 · GKZ Counter, Differential Cell · Hematology
Jan 1997 155d
CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL
K962305 · GKZ Counter, Differential Cell · Hematology
Jan 1997 203d
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL
K962768 · GKZ Counter, Differential Cell · Hematology
Jan 1997 203d
CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1
K964618 · GKZ Counter, Differential Cell · Hematology
Dec 1996 69d
COULTER GEN-S SYSTEM
K962988 · GKL Counter, Cell, Automated... · Hematology
Oct 1996 90d
COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
K961278 · GKZ Counter, Differential Cell · Hematology
Jul 1996 110d
FLOW-COUNT COULTER FLUOROSPHERES
K954688 · GKZ Counter, Differential Cell · Hematology
Feb 1996 141d
COULTER LINEARITY CONTROL
K955334 · JPK Mixture, Hematology... · Hematology
Feb 1996 80d
4C PLUS COULTER CELL CONTROL
K955016 · JPK Mixture, Hematology... · Hematology
Jan 1996 89d
COULTER Z 1
K952308 · GKL Counter, Cell, Automated... · Hematology
Oct 1995 142d
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
K950742 · GKZ Counter, Differential Cell · Hematology
Aug 1995 189d
COULTER MH025A
K950949 · GKZ Counter, Differential Cell · Hematology
Jul 1995 140d
ONYX
K943967 · GKZ Counter, Differential Cell · Hematology
Mar 1995 203d
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