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FASTPACK VITAMIN D - Immunoassay, Calibrators, Controls, Verifiers
FDA 510(k)Class II (US FDA 510(k))
510(k) K123983
Identifiers
- 510(k) Number
- K123983 FDA 510(k)
- FDA Product Code
- MRG FDA 510(k)
- Models / Variants
- Fastpack Vitamin D FDA 510(k)Immunoassay, Calibrators, Controls, Verifiers FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1825 FDA 510(k)
- Regulation Number
- 862.1825 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
FASTPACK VITAMIN D - Immunoassay, Calibrators, Controls, Verifiers by Qualigen Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 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 | K123983 | Class II | Active |
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Manufacturer
- Manufacturer
- Qualigen Inc.
- FDA Applicant
- Qualigen, Inc.
Sources (1)
- FDA 510(k) K123983 24 fields · synced Jun 18, 2026