BIOTROL ALBUMIN— 510(k) K885094
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K885094 for BIOTROL ALBUMIN, Substantially Equivalent on 1989-02-10. Applicant: Biotrol, USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code CIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1035
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westchester, PA, US
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