CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER— 510(k) K946387
Substantially EquivalentCapintec, Inc.
FDA 510(k) clearance K946387 for CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER, Substantially Equivalent on 1995-03-30. Applicant: Capintec, Inc.. Device class: 1.
Clearance details
- Applicant
- Capintec, Inc.
- Product code
- Code JJJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.2320
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
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