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. Device class: 2.
Clearance details
- Applicant
- Alfa Wassermann Diagnostics Technologies, LLC
- Product code
- Code CDN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
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