Dade Behring, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PT-MULTI-CALIBRATOR, MODEL OPAT07, DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST, DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
343
Total
343
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dade Behring, Inc. Toxicology ✕
37 devices
Cleared
Aug 24, 2007
ETOH FLEX REAGENT CARTRIDGE (DF22)
Toxicology
52d
Cleared
Sep 14, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
Toxicology
48d
Cleared
Sep 14, 2006
DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
Toxicology
45d
Cleared
Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
Toxicology
36d
Cleared
Aug 21, 2006
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS...
Toxicology
21d
Cleared
Jul 28, 2006
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE,...
Toxicology
10d
Cleared
Jul 18, 2006
DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0...
Toxicology
22d
Cleared
Jun 22, 2006
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
Toxicology
21d
Cleared
May 18, 2006
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
Toxicology
83d
Cleared
May 18, 2006
DIMENSION TACR CALIBRATOR, MODEL DC107
Toxicology
83d
Cleared
Feb 06, 2006
EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
Toxicology
98d
Cleared
Sep 12, 2005
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
Toxicology
48d
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