BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.— 510(k) K881702
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K881702 for BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P., Substantially Equivalent on 1988-05-27. Applicant: Biotrol, USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code CDT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1705
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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