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Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c As…
FDA 510(k)Class II (US FDA 510(k))
510(k) K160762
Identifiers
- 510(k) Number
- K160762 FDA 510(k)
- FDA Product Code
- LCP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7470 FDA 510(k)
- Regulation Number
- 864.7470 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c As… by Diazyme Laboratories — Class II — 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 | K160762 | Class II | Active |
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Manufacturer
- Manufacturer
- Diazyme Laboratories
Sources (1)
- FDA 510(k) K160762 24 fields · synced Jun 18, 2026