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PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysio…
FDA 510(k)Class I (US FDA 510(k))
510(k) K183205
Identifiers
- 510(k) Number
- K183205 FDA 510(k)
- FDA Product Code
- JQC FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.2050 FDA 510(k)
- Regulation Number
- 862.2050 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysio… by EmCyte Corporation — 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 | K183205 | Class I | Active |
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Manufacturer
- Manufacturer
- EmCyte Corporation
Sources (1)
- FDA 510(k) K183205 24 fields · synced Jun 18, 2026