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EASYQC - CHEMISTRY WITH ELECTROLYTES - Electrolytes Kit
FDA 510(k)Class II (US FDA 510(k))
510(k) K080404
by Medica Corp.
Identifiers
- 510(k) Number
- K080404 FDA 510(k)
- FDA Product Code
- JIX FDA 510(k)
- Models / Variants
- Easyqc - Chemistry With Electrolytes FDA 510(k)Chemistry FDA 510(k)Electrolytes Kit FDA 510(k)Chemistry Calibrator, Crea-U Claibrator FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
EASYQC - CHEMISTRY WITH ELECTROLYTES - Electrolytes Kit by Medica Corp. — Class II — FDA_510K — listed in FDA 510(k) — 4 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 | K080404 | Class II | Active |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA 510(k) K080404 24 fields · synced Jun 18, 2026