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St Aia-Pack Cystatin C, Model 025217
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
510(k) K093960
Identifiers
- 510(k) Number
- K093960 FDA 510(k)
- FDA Product Code
- NDY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1225 FDA 510(k)
- Regulation Number
- 862.1225 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
St Aia-Pack Cystatin C, Model 025217 by Tosoh Bioscience, Inc. — Class II — 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 II | Active |
| FDA 510(k) | United States | FDA_510K | K093960 | Class II | Active |
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Manufacturer
- Manufacturer
- Tosoh Bioscience, Inc.
Sources (2)
- FDA 510(k) K093960 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 19, 2026