← Back to catalogue
Free Testosterone AccuBind ELISA Test System
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K181017
Identifiers
- 510(k) Number
- K181017 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)
Free Testosterone AccuBind ELISA Test System by Monobind, Inc. — Class I — IVDR, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
IVDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K181017 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (2)
- FDA 510(k) K181017 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 19, 2026