ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT— 510(k) K113389
Substantially EquivalentAlfa Wassermann Diagnostic Technologies, Inc.
FDA 510(k) clearance K113389 for ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT, Substantially Equivalent on 2012-08-10. Applicant: Alfa Wassermann Diagnostic Technologies, Inc..
Clearance details
- Applicant
- Alfa Wassermann Diagnostic Technologies, Inc.
- Product code
- Code CDN
- 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.