BIOTROL TOTAL PROTEIN H.P.— 510(k) K882189
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K882189 for BIOTROL TOTAL PROTEIN H.P., Substantially Equivalent on 1988-07-01. Applicant: Biotrol, USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code CEK
- Device class
- Class 2
- Regulation
- 21 CFR 862.1635
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
Recent devices under product code CEK
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