Medical Device Manufacturer · US , Hialeah , FL

Coulter Immunology

16 submissions · 16 cleared · Since 1988
16
Total
16
Cleared
0
Denied

Coulter Immunology — FDA 510(k) Submissions

Coulter Immunology has submitted 16 FDA 510(k) premarket notifications since 1988, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, Products, Red-cell Lysing Products, Igg, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1
K922744 · GKZ Counter, Differential Cell · Hematology
Feb 1993 242d
CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1
K922745 · GKZ Counter, Differential Cell · Hematology
Feb 1993 242d
CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC
K910473 · GKZ Counter, Differential Cell · Hematology
Oct 1991 269d
COULTERCLONE
K911793 · GKZ Counter, Differential Cell · Hematology
Jul 1991 78d
COULTER CLONE T4 MONOCLONAL ANTIBODY
K893852 · GKZ Counter, Differential Cell · Hematology
Mar 1990 281d
COULTER CLONE T8 MONOCLONAL ANTIBODY
K893853 · GKZ Counter, Differential Cell · Hematology
Mar 1990 281d
COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY
K894179 · GKZ Counter, Differential Cell · Hematology
Feb 1990 241d
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI
K895917 · GKZ Counter, Differential Cell · Hematology
Dec 1989 80d
COULTER CLONE MO2
K884605 · GKZ Counter, Differential Cell · Hematology
Aug 1989 285d
COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)
K893419 · DEW Igg, Antigen, Antiserum,... · Microbiology
Aug 1989 93d
COULTER CLONE T3 MONOCLONAL ANTIBODY
K883710 · GKZ Counter, Differential Cell · Hematology
Feb 1989 157d
COULTER CLONE T1 MONOCLONAL ANTIBODY
K883753 · GKZ Counter, Differential Cell · Hematology
Feb 1989 154d
COULTER CLONE B4 MONOCLONAL ANTIBODY
K884020 · GKZ Counter, Differential Cell · Hematology
Feb 1989 134d
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI
K884346 · GKZ Counter, Differential Cell · Hematology
Dec 1988 74d
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
K883836 · GGK Products, Red-cell Lysing... · Hematology
Nov 1988 79d
COULTER CLONE B1 MONOCLONAL ANTIBODY
K882557 · GKZ Counter, Differential Cell · Hematology
Sep 1988 85d
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