Medical Device Manufacturer · US , Simi Valley , CA

Boehringer Mannheim Italia Spa - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1994

Recent clearances: ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT, EVATEST STRIP, EVENT TEST STRIP HCG

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Boehringer Mannheim Italia Spa Chemistry ✕

3 devices

1-3 of 3

Cleared Feb 29, 1996

ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT

Chemistry · 106d

Cleared Feb 25, 1994

Chemistry · 71d

Cleared Jan 27, 1994

EVENT TEST STRIP HCG

Chemistry · 72d