BIOTROL AMYLASE CNPG3— 510(k) K931141
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K931141 for BIOTROL AMYLASE CNPG3, Substantially Equivalent on 1993-05-26. Applicant: Biotrol, USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code CIJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Exton, PA, US
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