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
343 devices
326-343 of 343
Cleared Nov 04, 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722 · JIT
Chemistry · 14d
Cleared Oct 27, 1998
FERRITIN CALIBRATOR
K983548 · JIT
Immunology · 18d
Cleared Oct 13, 1998
COAGULATION FACTOR V DEFICIENT PLASMA
K981709 · GJT
Hematology · 162d
Cleared Oct 13, 1998
DRUG CALIBRATOR II
K982871 · DKB
Toxicology · 60d
Cleared Sep 30, 1998
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
K981711 · JPA
Hematology · 156d
Cleared Aug 25, 1998
DIMENSION(R) VALPROIC (VALP) ACID METHOD
K982880 · LEG
Toxicology · 11d
Cleared Aug 13, 1998
PREALBUMIN CALIBRATOR
K982292 · JIT
Chemistry · 44d
Cleared Aug 05, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K982591 · JJX
Chemistry · 12d
Cleared Jul 09, 1998
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210 · LJC
Microbiology · 16d
Cleared Jun 08, 1998
DADE TRU-LIQUID CARDIAC CONTROL
K981622 · JJX
Chemistry · 32d
Cleared May 26, 1998
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
K981099 · JHX
Chemistry · 61d
Cleared Apr 27, 1998
STRATUS CS CARDIAC TROPONIN I TESTPAK
K981098 · MMI
Chemistry · 32d
Cleared Apr 27, 1998
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K981102 · DDR
Immunology · 32d
Cleared Apr 16, 1998
STRATUS CS CKMB CALPAK
K981097 · JIT
Chemistry · 21d
Cleared Apr 16, 1998
STRATUS CS TROP CALPAK
K981100 · JIT
Chemistry · 21d
Cleared Apr 15, 1998
STRATUS CS MYO CALPAK
K981101 · JIT
Chemistry · 20d
Cleared Sep 28, 1982
EMIT-AMD AMIKACIN ASSAY
K822657 · KLQ
Chemistry · 25d
Cleared Oct 10, 1978
EMIT METHATREXATE ASSAY
K781381 · LAO
Toxicology · 60d

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