Dade Behring, Inc. - FDA 510(k) Cleared Devices
343
Total
343
Cleared
0
Denied
343 devices
Cleared
Jul 13, 2006
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
Chemistry
22d
Cleared
Jul 10, 2006
DIMENSION VISTA FLEX REAGENT CARTRIDGES
Chemistry
27d
Cleared
Jul 10, 2006
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
Chemistry
24d
Cleared
Jul 06, 2006
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
Immunology
52d
Cleared
Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
Chemistry
48d
Cleared
Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
Chemistry
60d
Cleared
Jun 22, 2006
DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
Toxicology
21d
Cleared
May 31, 2006
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
Chemistry
27d
Cleared
May 25, 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX...
Chemistry
22d
Cleared
May 19, 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
Chemistry
169d
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
May 10, 2006
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE,...
Chemistry
27d
Cleared
May 04, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
Chemistry
80d
Cleared
Apr 14, 2006
DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE...
Chemistry
113d
Cleared
Apr 06, 2006
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
Chemistry
51d
Cleared
Apr 06, 2006
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK...
Chemistry
36d
Cleared
Apr 06, 2006
DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
Chemistry
28d
Cleared
Mar 29, 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
Chemistry
177d
Cleared
Mar 28, 2006
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
Immunology
147d
Cleared
Mar 28, 2006
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
Immunology
147d
Cleared
Mar 23, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN...
Microbiology
43d
Cleared
Mar 16, 2006
N ANTISERA TO HUMAN CERULOPLASMIN
Immunology
135d
Cleared
Mar 16, 2006
N ANTISERA TO HUMAN TRANSFERRIN
Immunology
135d
Cleared
Mar 09, 2006
DIMENSION IRON CALIBRATOR
Chemistry
36d
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