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
FDA 510(k) Regulatory Record - Coulter Corp. Chemistry ✕
17 devices
Cleared
Nov 27, 1991
COULTER CARBON DIOXIDE REAGENT
Chemistry
50d
Cleared
Jul 31, 1990
COULTER HDL - CHOLESTEROL REAGENT
Chemistry
78d
Cleared
Jun 28, 1990
COULTER CREATININE REAGENT
Chemistry
45d
Cleared
Jun 12, 1990
COULTER SERUM IRON/UIBC REAGENT
Chemistry
29d
Cleared
Jun 12, 1990
COULTER UREA NITROGEN REAGENT
Chemistry
29d
Cleared
Jun 12, 1990
COULTER DIRECT BILIRUBIN
Chemistry
27d
Cleared
Jun 12, 1990
COULTER CARBON DIOXIDE REAGENT
Chemistry
26d
Cleared
May 30, 1990
COULTER ALBUMIN REAGENT
Chemistry
75d
Cleared
May 23, 1990
COULTER CK (CREATINE KINASE) REAGENT
Chemistry
68d
Cleared
Apr 25, 1990
COULTER TOTAL BILIRUBIN REAGENT
Chemistry
40d
Cleared
Apr 16, 1990
COULTER GAMMA-GT (GGT) REAGENT
Chemistry
31d
Cleared
Apr 03, 1990
COULTER AMYLASE REAGENT
Chemistry
76d
Cleared
Apr 03, 1990
COULTER CALCIUM REAGENT
Chemistry
76d
Cleared
Mar 29, 1990
COULTER MAGNESIUM REAGENT
Chemistry
13d
Cleared
Feb 08, 1990
COULTER PHOSPHORUS REAGENT
Chemistry
22d
Cleared
Feb 08, 1990
COULTER ALP (ALK PHOS) REAGENT
Chemistry
22d
Cleared
Feb 27, 1989
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
Chemistry
132d