Abusign Doa 3, Doa, Coc/Thc/Opi, Accusign Doa 3, Biosign Doa 3, Coc/Thc/Oopi
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K954571 FDA 510(k)
- FDA Product Code
- DIO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3250 FDA 510(k)
- Regulation Number
- 862.3250 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is an Enzyme Immunoassay for Cocaine and Cocaine Metabolites, as defined in the device name and openfda fields. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway.
It is authorized under FDA 510(k) with K number K954571 and is classified as a Class II device. The device is intended for use in clinical toxicology settings, as indicated by the advisory committee and medical specialty description.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954571 | Class II | Active |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA 510(k) K954571 24 fields · synced Sep 23, 2026