← Back to catalogue
Fastpack Total Testosterone Immunoassay
FDA 510(k)Class I (US FDA 510(k))
510(k) K021972
Identifiers
- 510(k) Number
- K021972 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 Total Testosterone 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 | K021972 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Qualigen Inc.
- FDA Applicant
- Qualigen, Inc.
Sources (1)
- FDA 510(k) K021972 24 fields · synced Jun 18, 2026