Identifiers
- 510(k) Number
- K940502 FDA 510(k)
- FDA Product Code
- KIR FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.2280 FDA 510(k)
- Regulation Number
- 864.2280 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Fresh Frozen Cells by Diagnostic Hybrids, Inc. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
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 | K940502 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA 510(k) K940502 24 fields · synced Jun 18, 2026