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. Chemistry ✕
134 devices
Cleared
Mar 13, 2008
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT...
Chemistry
83d
Cleared
Feb 21, 2008
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
Chemistry
113d
Cleared
Jan 03, 2008
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
Chemistry
65d
Cleared
Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
Chemistry
78d
Cleared
Nov 13, 2007
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4...
Chemistry
195d
Cleared
Oct 17, 2007
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1...
Chemistry
48d
Cleared
Aug 17, 2007
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
Chemistry
45d
Cleared
Aug 04, 2007
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
Chemistry
36d
Cleared
Jun 13, 2007
DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
Chemistry
77d
Cleared
Mar 21, 2007
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND...
Chemistry
103d
Cleared
Mar 19, 2007
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
Chemistry
90d
Cleared
Feb 23, 2007
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1...
Chemistry
81d
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