Dade Behring, Inc. - FDA 510(k) Cleared Devices
343
Total
343
Cleared
0
Denied
343 devices
Cleared
Jan 12, 2004
DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR,...
Chemistry
66d
Cleared
Dec 24, 2003
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
Chemistry
50d
Cleared
Nov 26, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
Microbiology
22d
Cleared
Nov 07, 2003
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
Chemistry
66d
Cleared
Oct 31, 2003
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
Chemistry
72d
Cleared
Oct 31, 2003
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
Chemistry
72d
Cleared
Oct 30, 2003
DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A)...
Chemistry
51d
Cleared
Oct 06, 2003
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
Toxicology
47d
Cleared
Sep 08, 2003
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540....
Hematology
130d
Cleared
Sep 05, 2003
N/T PROTEIN CONTROL
Immunology
46d
Cleared
Aug 07, 2003
N LATEX IGM
Immunology
38d
Cleared
Jul 31, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN...
Microbiology
71d
Cleared
Jul 23, 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
Toxicology
70d
Cleared
Jun 06, 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
Toxicology
67d
Cleared
Jun 02, 2003
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
Chemistry
54d
Cleared
May 15, 2003
TPSA FLEX REAGENT CARTRIDGE
Immunology
16d
Cleared
Feb 13, 2003
N LATEX IGA
Immunology
69d
Cleared
Jan 16, 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
Hematology
132d
Cleared
Jan 16, 2003
MODIFICATION TO STANDARD HUMAN PLASMA
Hematology
118d
Cleared
Dec 16, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN...
Microbiology
70d
Cleared
Dec 13, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN...
Microbiology
52d
Cleared
Nov 27, 2002
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
Hematology
82d
Cleared
Nov 01, 2002
CONTROL PLASMA N
Hematology
29d
Cleared
Nov 01, 2002
CONTROL PLASMA P
Hematology
29d
Cleared
Oct 16, 2002
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
Chemistry
30d
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