← Back to catalogue
Accusign Doa3, Doa, Coc/Thc/Opi2000 Doa3 +2 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K992422
Identifiers
- 510(k) Number
- K992422 FDA 510(k)
- FDA Product Code
- DJG FDA 510(k)
- Models / Variants
- Accusign Doa3, Doa, Coc/Thc/Opi2000 Doa3 FDA 510(k)Biosign Doa3, Coc/Thc/Opi2000 FDA 510(k)Status Ds Coc/Thc/Opi2000 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Accusign Doa3, Doa, Coc/Thc/Opi2000 Doa3 +2 more models by Princeton Biomeditech Corp. — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K992422 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA 510(k) K992422 24 fields · synced Jun 18, 2026