Dade Behring, Inc. - FDA 510(k) Cleared Devices
343
Total
343
Cleared
0
Denied
343 devices
Cleared
Jul 28, 1999
DADE BEHRING BFTII
Hematology
222d
Cleared
Jul 15, 1999
N PROTEIN STANDARD UY
Chemistry
57d
Cleared
Jul 07, 1999
N LATEX IGE MONO REAGENT
Immunology
43d
Cleared
Jul 01, 1999
OPUS TROPONIN I CALIBRATOR
Chemistry
85d
Cleared
Jul 01, 1999
OPUS TROPONIN I (CTN) TEST MODULES
Chemistry
85d
Cleared
Jun 25, 1999
N/T PROTEIN CONTROL LC
Chemistry
37d
Cleared
Jun 22, 1999
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
Chemistry
272d
Cleared
Jun 01, 1999
MODIFICATION OF N PROTEIN STANDARD SL
Chemistry
55d
Cleared
May 19, 1999
MODIFICATION OF N/T PROTEIN CONTROL SL
Chemistry
42d
Cleared
Apr 16, 1999
REVISED C-REACTIVE PROTEIN CALIBRATOR
Immunology
35d
Cleared
Apr 16, 1999
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
Immunology
35d
Cleared
Mar 31, 1999
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
Toxicology
63d
Cleared
Mar 25, 1999
IGG FLEX REAGENT CARTRIDGE
Immunology
31d
Cleared
Mar 25, 1999
IMMUNOGLOBULIN A TEST SYSTEM
Immunology
31d
Cleared
Mar 22, 1999
IGM FLEX REAGENT CARTRIDGE
Immunology
28d
Cleared
Mar 22, 1999
DIMENSION SPECIAL PROTEIN CALIBRATOR
Immunology
28d
Cleared
Feb 16, 1999
DIMENSION DRUG CALIBRATOR II, MODEL DC49B
Toxicology
20d
Cleared
Jan 13, 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
Chemistry
58d
Cleared
Jan 11, 1999
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT...
Chemistry
73d
Cleared
Dec 14, 1998
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
Immunology
28d
Cleared
Dec 14, 1998
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
Chemistry
28d
Cleared
Dec 14, 1998
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
Chemistry
21d
Cleared
Dec 10, 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
Immunology
17d
Cleared
Nov 18, 1998
DIMENSION AHDL CALIBRATOR
Chemistry
19d
Cleared
Nov 04, 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
Chemistry
14d
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