BIOTROL LACTATE DEHYDROGENASE (L-P)— 510(k) K905683
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K905683 for BIOTROL LACTATE DEHYDROGENASE (L-P), Substantially Equivalent on 1991-03-11. Applicant: Biotrol, USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code CFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1440
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westchester, PA, US
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