Coulter Immunology is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Coulter Immunology - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
Coulter Immunology has 16 FDA 510(k) cleared hematology devices. Based in Hialeah, US.
Historical record: 16 cleared submissions from 1988 to 1993.
Browse the complete list of FDA 510(k) cleared hematology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Coulter Immunology
16 devices
Cleared
Feb 05, 1993
CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1
Hematology
242d
Cleared
Feb 05, 1993
CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1
Hematology
242d
Cleared
Oct 31, 1991
CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC
Hematology
269d
Cleared
Jul 09, 1991
COULTERCLONE
Hematology
78d
Cleared
Mar 02, 1990
COULTER CLONE T4 MONOCLONAL ANTIBODY
Hematology
281d
Cleared
Mar 02, 1990
COULTER CLONE T8 MONOCLONAL ANTIBODY
Hematology
281d
Cleared
Feb 12, 1990
COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY
Hematology
241d
Cleared
Dec 29, 1989
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI
Hematology
80d
Cleared
Aug 15, 1989
COULTER CLONE MO2
Hematology
285d
Cleared
Aug 03, 1989
COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)
Microbiology
93d
Cleared
Feb 03, 1989
COULTER CLONE T3 MONOCLONAL ANTIBODY
Hematology
157d
Cleared
Feb 03, 1989
COULTER CLONE T1 MONOCLONAL ANTIBODY
Hematology
154d