BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL— 510(k) K872777
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K872777 for BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL, Substantially Equivalent on 1987-08-26. Applicant: Biotrol, USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Berwyn, PA, US
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