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Easyra Alb Reagent And Easyra Alp Reagent (10218 +4 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K080874
by Medica Corp.
Identifiers
- 510(k) Number
- K080874 FDA 510(k)
- FDA Product Code
- CIX FDA 510(k)
- Models / Variants
- 10218 FDA 510(k)10214 FDA 510(k)Easyra Ast Reagent FDA 510(k)Model 10206 FDA 510(k)Easyra Co2 Reagent FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1035 FDA 510(k)
- Regulation Number
- 862.1035 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Easyra Alb Reagent And Easyra Alp Reagent (10218 +4 more) by Medica Corp. — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080874 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K080874 24 fields · synced Jun 18, 2026