BIOTROL CALCIUM MONOREACTIF— 510(k) K891061
Substantially EquivalentBiotrol, USA, Inc.
FDA 510(k) clearance K891061 for BIOTROL CALCIUM MONOREACTIF, Substantially Equivalent on 1989-08-10. Applicant: Biotrol, USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotrol, USA, Inc.
- Product code
- Code CJY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westchester, PA, US
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