Identifiers
- 510(k) Number
- K101388 FDA 510(k)
- FDA Product Code
- CDZ FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1680 FDA 510(k)
- Regulation Number
- 862.1680 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Fastpack Testo Immunoassay by Qualigen Inc. — 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 | K101388 | Class I | Active |
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Manufacturer
- Manufacturer
- Qualigen Inc.
- FDA Applicant
- Qualigen, Inc.
Sources (1)
- FDA 510(k) K101388 24 fields · synced Jun 18, 2026