Beckman Coulter, Inc. - FDA 510(k) Cleared Devices
269
Total
269
Cleared
0
Denied
116 devices
Cleared
May 17, 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM...
Chemistry
120d
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
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 29, 1999
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
Chemistry
51d
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
Jul 09, 1998
VIGIL PROTEIN CONTROL
Chemistry
15d
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
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