Medical Device Manufacturer · US , West Caldwell , NJ

Alfa Wassermann Diagnostic Technologies, LLC - FDA 510(k) Cleared Dev...

2 submissions · 2 cleared · Since 2013

Recent clearances: ACE Hemoglobin A1c (HbA1c) Reagent, ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Alfa Wassermann Diagnostic Technologies, LLC Chemistry ✕

2 devices

1-2 of 2

Cleared Feb 27, 2018

ACE Hemoglobin A1c (HbA1c) Reagent

Chemistry · 363d

Cleared Aug 15, 2013

ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT

Chemistry · 97d