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ImmunoCAP Specific IgE +5 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K150854
by Phadia AB
Identifiers
- 510(k) Number
- K150854 FDA 510(k)
- FDA Product Code
- DHB FDA 510(k)
- Models / Variants
- ImmunoCAP Specific IgE FDA 510(k)ImmunoCAP Allergen f439, Hazelnut FDA 510(k)ImmunoCAP Allergen f440, Hazelnut FDA 510(k)ImmunoCAP Allergen f441, Walnut FDA 510(k)ImmunoCAP Allergen f442, Walnut FDA 510(k)ImmunoCAP Allergen f443, Cashew nut FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5750 FDA 510(k)
- Regulation Number
- 866.5750 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ImmunoCAP Specific IgE +5 more models by Phadia AB — Class II — FDA_510K — listed in FDA 510(k) — 6 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 | K150854 | Class II | Active |
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Manufacturer
- Manufacturer
- Phadia AB
Sources (1)
- FDA 510(k) K150854 24 fields · synced Jun 18, 2026