Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
270
Total
270
Cleared
0
Denied
270 devices
Cleared
Oct 05, 2000
PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100
Chemistry
27d
Cleared
Aug 31, 2000
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS...
Microbiology
21d
Cleared
Aug 22, 2000
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER,...
Chemistry
57d
Cleared
Jun 02, 2000
SYNCHRON CONTROL
Chemistry
23d
Cleared
May 17, 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM...
Chemistry
120d
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
Mar 28, 2000
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
Chemistry
99d
Cleared
Mar 20, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
Chemistry
17d
Cleared
Feb 18, 2000
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315,...
Chemistry
28d
Cleared
Feb 10, 2000
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
Chemistry
50d
Cleared
Feb 03, 2000
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
Chemistry
55d
Cleared
Feb 03, 2000
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
Chemistry
55d
Cleared
Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
Immunology
105d
Cleared
Feb 01, 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
Immunology
105d
Cleared
Jan 18, 2000
ACCESS HYBRITECH PSA QC, MODEL 37209
Immunology
36d
Cleared
Jan 14, 2000
ACCESS OSTASE QC
Chemistry
25d
Cleared
Jan 14, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309,...
Chemistry
22d
Cleared
Jan 12, 2000
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
Chemistry
21d
Cleared
Jan 11, 2000
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
Toxicology
50d
Cleared
Jan 05, 2000
ACCESS HYBRITECH FREE PSA QC, MODEL 37219
Immunology
103d
Cleared
Nov 26, 1999
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
Immunology
78d
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
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