BIOTROL URIC ACID ENZYMATIQUE UV H.P.— 510(k) K875320
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K875320 for BIOTROL URIC ACID ENZYMATIQUE UV H.P., Substantially Equivalent on 1988-02-01. Applicant: Biotrol, USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code CDO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1775
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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