Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
269
Total
269
Cleared
0
Denied
FDA 510(k) cleared devices by Beckman Coulter, Inc. Toxicology ✕
20 devices
Cleared
Feb 07, 2011
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
Toxicology
82d
Cleared
Oct 05, 2004
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
Toxicology
7d
Cleared
Jul 15, 2003
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT
Toxicology
28d
Cleared
Apr 29, 2003
SYNCHRON SYSTEMS OPIATE REAGENT
Toxicology
29d
Cleared
Nov 07, 2002
MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
Toxicology
55d
Cleared
Feb 15, 2002
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
Toxicology
57d
Cleared
Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
Toxicology
89d
Cleared
Nov 27, 2000
SYNCHRON CONTROL
Toxicology
14d
Cleared
May 05, 2000
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
Toxicology
72d
Cleared
Apr 14, 2000
SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT
Toxicology
59d
Cleared
Apr 10, 2000
SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
Toxicology
62d
Cleared
Jan 11, 2000
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
Toxicology
50d
Cleared
Nov 26, 1999
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
Toxicology
43d
Cleared
Nov 09, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
Toxicology
61d
Cleared
Jan 29, 1999
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
Toxicology
71d
Cleared
Dec 30, 1998
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
Toxicology
68d
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