CLEARPLAN EASY— 510(k) K894579
Substantially EquivalentUnipath , Ltd.
FDA 510(k) clearance K894579 for CLEARPLAN EASY, Substantially Equivalent on 1989-10-12. Applicant: Unipath , Ltd.. Device class: 1.
Clearance details
- Applicant
- Unipath , Ltd.
- Product code
- Product code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford Mk41 Oqg, GB
Recent devices under product code CEP
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