Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
269
Total
269
Cleared
0
Denied
116 devices
Cleared
Mar 19, 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
Chemistry
56d
Cleared
Jun 21, 2007
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN...
Chemistry
73d
Cleared
Jun 01, 2007
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
Chemistry
25d
Cleared
Jun 01, 2007
SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
Chemistry
25d
Cleared
Jun 01, 2007
SYNCHRON SYSTEMS CREATININE REAGENT
Chemistry
25d
Cleared
May 04, 2007
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
Chemistry
59d
Cleared
Feb 01, 2007
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
Chemistry
16d
Cleared
Sep 15, 2006
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
Chemistry
140d
Cleared
Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
Chemistry
25d
Cleared
Apr 28, 2006
SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
Chemistry
23d
Cleared
Apr 26, 2006
DRI-STAT ACID PHOSPHATASE REAGENT
Chemistry
120d
Cleared
Apr 21, 2006
FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208
Chemistry
30d
Cleared
Feb 27, 2006
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
Chemistry
26d
Cleared
Dec 16, 2005
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR
Chemistry
44d
Cleared
Jun 13, 2005
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
Chemistry
25d
Cleared
Mar 28, 2005
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
Chemistry
91d
Cleared
Feb 09, 2005
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Chemistry
12d
Cleared
Nov 17, 2004
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
Chemistry
68d
Cleared
Nov 12, 2004
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
Chemistry
80d
Cleared
Sep 16, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS...
Chemistry
34d
Cleared
Sep 16, 2004
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
Chemistry
23d
Cleared
Aug 18, 2004
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
Chemistry
62d
Cleared
Jun 07, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
Chemistry
74d
Cleared
Mar 24, 2004
ACCESS DHEA-S REAGENT ASSAY
Chemistry
57d
Cleared
Dec 19, 2003
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS,...
Chemistry
32d
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