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REP DIRECT-SEP CHOLESTEROL-15 KIT - Cholesterol-4 Kit
FDA 510(k)Class I (US FDA 510(k))
510(k) K935162
Identifiers
- 510(k) Number
- K935162 FDA 510(k)
- FDA Product Code
- JHO FDA 510(k)
- Models / Variants
- Rep Direct-Sep Cholesterol-15 Kit FDA 510(k)Cholesterol-8 Kit FDA 510(k)Cholesterol-4 Kit FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1475 FDA 510(k)
- Regulation Number
- 862.1475 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
REP DIRECT-SEP CHOLESTEROL-15 KIT - Cholesterol-4 Kit by Helena Laboratories — Class I — FDA_510K — listed in FDA 510(k) — 3 models
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 | K935162 | Class I | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K935162 24 fields · synced Jun 19, 2026