BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST— 510(k) K881311
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K881311 for BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST, Substantially Equivalent on 1988-04-28. Applicant: Biotrol, USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code JQB
- Device class
- Class 1
- Regulation
- 21 CFR 862.1360
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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