ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT— 510(k) K131351
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, LLC
FDA 510(k) clearance K131351 for ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT, Substantially Equivalent on 2013-08-15. Applicant: Alfa Wassermann Diagnostic Technologies, LLC.
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, LLC
- Product code
- Code CJE
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.