ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT— 510(k) K131488
Substantially EquivalentAlfa Wassermann Diagnostics Technologies, LLC
FDA 510(k) clearance K131488 for ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT, Substantially Equivalent on 2013-08-19. Applicant: Alfa Wassermann Diagnostics Technologies, LLC. Device class: 2.
Clearance details
- Applicant
- Alfa Wassermann Diagnostics Technologies, LLC
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
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