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SPIFE IFE-15 PENTAVALENT - Model 3457
FDA 510(k)Class II (US FDA 510(k))
510(k) K061069
Identifiers
- 510(k) Number
- K061069 FDA 510(k)
- FDA Product Code
- CFF FDA 510(k)
- Models / Variants
- 3456 FDA 510(k)Spife Ife-9 Pentavalent Kit FDA 510(k)Model 3457 FDA 510(k)Spift Ife-6 Pentavalent Kit FDA 510(k)Model 3458 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5510 FDA 510(k)
- Regulation Number
- 866.5510 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
SPIFE IFE-15 PENTAVALENT - Model 3457 by Helena Laboratories — 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 | K061069 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K061069 24 fields · synced Jun 18, 2026