ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT— 510(k) K123322
Substantially EquivalentAlfa Wassermann Diagnostics Technologies, LLC
FDA 510(k) clearance K123322 for ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT, Substantially Equivalent on 2013-05-21. Applicant: Alfa Wassermann Diagnostics Technologies, LLC.
Clearance details
- Applicant
- Alfa Wassermann Diagnostics Technologies, LLC
- 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.