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

126-134 of 134

Cleared Aug 13, 1998

PREALBUMIN CALIBRATOR

Chemistry · 44d

Cleared Aug 05, 1998

DADE TRU-LIQUID CARDIAC CONTROL

Chemistry · 12d

Cleared Jun 08, 1998

DADE TRU-LIQUID CARDIAC CONTROL

Chemistry · 32d

Cleared May 26, 1998

STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK

Chemistry · 61d

Cleared Apr 27, 1998

STRATUS CS CARDIAC TROPONIN I TESTPAK

Chemistry · 32d

Cleared Apr 16, 1998

STRATUS CS CKMB CALPAK

Chemistry · 21d

Cleared Apr 16, 1998

STRATUS CS TROP CALPAK

Chemistry · 21d

Cleared Apr 15, 1998

STRATUS CS MYO CALPAK

Chemistry · 20d

Cleared Sep 28, 1982

EMIT-AMD AMIKACIN ASSAY

Chemistry · 25d

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