Identifiers
- 510(k) Number
- K993812 FDA 510(k)
- FDA Product Code
- JSM FDA 510(k)
- Models / Variants
- R96 FDA 510(k)Viral Transport FDA 510(k)Model R99 FDA 510(k)Cvm Transport Kit FDA 510(k)Model R96 K FDA 510(k)Viral Transport Kit FDA 510(k)Model R99 K FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.2390 FDA 510(k)
- Regulation Number
- 866.2390 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cvm Transport (R96 +6 more) by Hardy Diagnostics — Class I — FDA_510K — listed in FDA 510(k) — 7 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 | K993812 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA 510(k) K993812 24 fields · synced Jun 19, 2026