Coulter Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Coulter Corp. - FDA 510(k) Cleared Devices
Recent clearances: COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES, COULTER Z2 ANALYZER, RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
51
Total
51
Cleared
0
Denied
Coulter Corp. has 51 FDA 510(k) cleared medical devices. Based in Hialeah, US.
Historical record: 51 cleared submissions from 1989 to 2000. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Coulter Corp. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Coulter Corp.
51 devices
Cleared
Apr 20, 2000
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
Hematology
197d
Cleared
May 11, 1999
COULTER Z2 ANALYZER
Hematology
41d
Cleared
Apr 26, 1999
RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
Hematology
83d
Cleared
Apr 13, 1999
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT...
Hematology
84d
Cleared
Apr 01, 1999
COULTER AC T DIFF 2 ANALYZER
Hematology
55d
Cleared
Mar 16, 1999
IMMUNO-TROL CONTROL CELLS
Hematology
112d
Cleared
Nov 09, 1998
CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
Hematology
143d
Cleared
Nov 05, 1998
CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
Hematology
139d
Cleared
Sep 24, 1998
CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH...
Hematology
97d
Cleared
Oct 29, 1997
COULTER AC.T DIFF ANALYZER
Hematology
35d
Cleared
Jun 30, 1997
COULTER ACT TRON CELL CONTROL
Hematology
69d
Cleared
Mar 06, 1997
COULTER AC.T SERIES ANALYZER
Hematology
83d
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