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Cryocheck Prekallikrein Deficient Plalsma (Fdpk10 +3 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K990296
Identifiers
- 510(k) Number
- K990296 FDA 510(k)
- FDA Product Code
- GJT FDA 510(k)
- Models / Variants
- Fdpk10 FDA 510(k)10 (10 X 1.0 Ml) FDA 510(k)Fdpk10 FDA 510(k)25 (25 X 1.0ml) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7290 FDA 510(k)
- Regulation Number
- 864.7290 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cryocheck Prekallikrein Deficient Plalsma (Fdpk10 +3 more) by Precision Biologic — Class II — FDA_510K — listed in FDA 510(k) — 4 models
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 | K990296 | Class II | Active |
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Manufacturer
- Manufacturer
- Precision Biologic
Sources (1)
- FDA 510(k) K990296 24 fields · synced Jun 18, 2026