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Architect Shbg Reagent Kit, Architect Shbg Calibrator Kit, And Architect Shbg C…
FDA 510(k)Class I (US FDA 510(k))
510(k) K060818
by Biokit, S.a.
Identifiers
- 510(k) Number
- K060818 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)
Architect Shbg Reagent Kit, Architect Shbg Calibrator Kit, And Architect Shbg C… by Biokit, S.a. — Class I — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060818 | Class I | Active |
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Manufacturer
- Manufacturer
- Biokit, S.a.
Sources (1)
- FDA 510(k) K060818 24 fields · synced Jun 18, 2026