Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
Cleared
May 03, 1999
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
Immunology
60d
Cleared
Jan 29, 1999
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
Toxicology
71d
Cleared
Jan 29, 1999
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
Chemistry
51d
Cleared
Dec 30, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
Toxicology
68d
Cleared
Dec 23, 1998
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
Chemistry
42d
Cleared
Dec 21, 1998
SYNCHRON SYSTEMS LIPID CALIBRATOR
Chemistry
66d
Cleared
Dec 14, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY...
Immunology
82d
Cleared
Nov 25, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
Immunology
22d
Cleared
Nov 05, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
Toxicology
57d
Cleared
Nov 04, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
Toxicology
51d
Cleared
Oct 28, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1
Toxicology
7d
Cleared
Oct 14, 1998
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
Toxicology
54d
Cleared
Sep 24, 1998
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205,...
Immunology
111d
Cleared
Jul 09, 1998
VIGIL PROTEIN CONTROL
Chemistry
15d
Cleared
Jul 06, 1998
VIGIL HEMOGLOBIN (HBALC) CONTROLS
Hematology
27d
Cleared
Jun 12, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
Immunology
35d
Cleared
Jun 12, 1998
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
Chemistry
16d
Cleared
Jan 29, 1996
ACCESS FOLATE ASSAY (MODIFICATION)
Chemistry
119d
Cleared
Aug 26, 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
Immunology
57d
Cleared
Oct 12, 1993
ACCESS FOLATE ASSAY
Immunology
120d
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