Medical Device Manufacturer · US , West Caldwell , NJ

Alfa Wassermann Diagnostics Technologies, LLC - FDA 510(k) Cleared De...

3 submissions · 3 cleared · Since 2012

3

Total

3

Cleared

0

Denied

Alfa Wassermann Diagnostics Technologies, LLC — FDA 510(k) Products and Clearance History Chemistry ✕

3 devices

1-3 of 3

Cleared Aug 19, 2013

ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT...

Chemistry · 88d

Cleared May 21, 2013

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK...

Chemistry · 207d

Cleared Aug 27, 2012

ACE MAGNESIUM REGENT

Chemistry · 26d