Medical Device Manufacturer · US , Newark, , DE

Dade Behring, Inc. - FDA 510(k) Cleared Devices

343 submissions · 343 cleared · Since 1978
343
Total
343
Cleared
0
Denied
134 devices
101-125 of 134
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · CEM
Chemistry · 65d
Cleared Mar 13, 2001
N LATEX CYSTATIN C
K003503 · NDY
Chemistry · 120d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · JIT
Chemistry · 28d
Cleared Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG,...
K003696 · DHA
Chemistry · 56d
Cleared Nov 27, 2000
N/T PROTEIN CONTROL SL
K002852 · JJY
Chemistry · 75d
Cleared Oct 11, 2000
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL...
K002551 · LEG
Chemistry · 55d
Cleared Oct 11, 2000
EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL
K002974 · LDP
Chemistry · 55d
Cleared Oct 05, 2000
N PROTEIN STANDARD SL
K002804 · JIX
Chemistry · 27d
Cleared Jan 28, 2000
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · JMO
Chemistry · 53d
Cleared Jan 20, 2000
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
K994114 · JIS
Chemistry · 45d
Cleared Nov 30, 1999
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
K993310 · JJY
Chemistry · 57d
Cleared Jul 15, 1999
N PROTEIN STANDARD UY
K991705 · JIT
Chemistry · 57d
Cleared Jul 01, 1999
OPUS TROPONIN I CALIBRATOR
K991176 · JIT
Chemistry · 85d
Cleared Jul 01, 1999
OPUS TROPONIN I (CTN) TEST MODULES
K991177 · MMI
Chemistry · 85d
Cleared Jun 25, 1999
N/T PROTEIN CONTROL LC
K991704 · JJY
Chemistry · 37d
Cleared Jun 22, 1999
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
K983344 · CGA
Chemistry · 272d
Cleared Jun 01, 1999
MODIFICATION OF N PROTEIN STANDARD SL
K991181 · JIX
Chemistry · 55d
Cleared May 19, 1999
MODIFICATION OF N/T PROTEIN CONTROL SL
K991182 · JJY
Chemistry · 42d
Cleared Jan 13, 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
K984067 · JHX
Chemistry · 58d
Cleared Jan 11, 1999
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT...
K983849 · JHM
Chemistry · 73d
Cleared Dec 14, 1998
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
K984093 · MMI
Chemistry · 28d
Cleared Dec 14, 1998
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
K984193 · JIT
Chemistry · 21d
Cleared Nov 18, 1998
DIMENSION AHDL CALIBRATOR
K983850 · JIT
Chemistry · 19d
Cleared Nov 04, 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693 · JIT
Chemistry · 14d
Cleared Nov 04, 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722 · JIT
Chemistry · 14d

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