ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT— 510(k) K131515
Substantially EquivalentAlfa Wassermann
FDA 510(k) clearance K131515 for ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT, Substantially Equivalent on 2013-08-14. Applicant: Alfa Wassermann. Device class: 2.
Clearance details
- Applicant
- Alfa Wassermann
- Product code
- Code KLI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Caldwell, NJ, US
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