BIOTROL BUN ENZYMATIQUE UV H.P.— 510(k) K881366
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K881366 for BIOTROL BUN ENZYMATIQUE UV H.P., Substantially Equivalent on 1988-05-16. Applicant: Biotrol, USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code CDQ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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