← Back to catalogue
Rep Hdl-8 Kit, No. 3188, Rep Hdl-16 Kit, No. 3187
FDA 510(k)Class I (US FDA 510(k))
510(k) K894366
Identifiers
- 510(k) Number
- K894366 FDA 510(k)
- FDA Product Code
- LBT 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 Hdl-8 Kit, No. 3188, Rep Hdl-16 Kit, No. 3187 by Helena Laboratories — Class I — FDA_510K — listed in FDA 510(k) — 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 | K894366 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K894366 24 fields · synced Jun 18, 2026