Medical Device Manufacturer · US , Mchenry , IL

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

145 submissions · 145 cleared · Since 1976

145

Total

145

Cleared

0

Denied

FDA 510(k) Regulatory Record - Behring Diagnostics, Inc. Toxicology ✕

8 devices

1-8 of 8

Cleared Oct 27, 1997

OPUS HLH CONTROLS

Toxicology · 20d

Cleared Jul 22, 1997

Toxicology · 53d

Cleared Jun 25, 1997

EMIT II OPIATES 300/2000 ASSAY

Toxicology · 55d

Cleared Jun 25, 1997

EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)

Toxicology · 55d

Cleared Sep 04, 1996

EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS

Toxicology · 69d

Cleared Feb 23, 1996

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

Toxicology · 86d

Cleared Nov 20, 1995

OPUS TDM CONTROLS

Toxicology · 67d

Cleared Jul 03, 1995

OPUS PROCAINAMIDE

Toxicology · 97d