← Back to catalogue
Contrex Plus Low Control Solution
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K100747
Identifiers
- 510(k) Number
- K100747 FDA 510(k)
- FDA Product Code
- JJX FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1660 FDA 510(k)
- Regulation Number
- 862.1660 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Contrex Plus Low Control Solution by Apex Biotechnology Corp. — Class I — IVDD, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
IVDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K100747 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
Sources (2)
- FDA 510(k) K100747 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026