← Back to catalogue
Cybow Reader, Models 300 & 720
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K102188
by Dfi Co., Ltd
Identifiers
- 510(k) Number
- K102188 FDA 510(k)
- FDA Product Code
- KQO FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.2900 FDA 510(k)
- Regulation Number
- 862.2900 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cybow Reader, Models 300 & 720 by Dfi Co., Ltd — 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 | K102188 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dfi Co., Ltd
- FDA Applicant
- DFI Co., Ltd.
Sources (2)
- FDA 510(k) K102188 24 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 18, 2026