Platelet Aggregation Reagents
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K922800 FDA 510(k)
- FDA Product Code
- GHR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5700 FDA 510(k)
- Regulation Number
- 864.5700 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Platelet Aggregation Reagents are diagnostic reagents designed to evaluate platelet function by inducing aggregation in whole blood or platelet-rich plasma. These reagents facilitate the assessment of platelet reactivity, aiding in the diagnosis and monitoring of bleeding disorders, thrombotic conditions, and the effectiveness of antiplatelet therapies.
These reagents are supplied in concentrated forms, requiring minimal volumes per test, and are intended for use in hematology laboratories. They are classified as Class II devices under FDA regulations and comply with the In Vitro Diagnostic Regulation (IVDR). The reagents are not sterile and are intended for single-use, with specific product codes (e.g., GHR) and registration numbers (e.g., 1618982) for traceability.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CHRONO-LOG® Platelet Function Reagents - Avant Medical, Chrono Log Corporation CHRONO-PAR Collagen Reagent, High Concentration ..., PDF Chrono-par®And Chrono-lume® Reagents for Platelet Function Testing ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K922800 | Class II | Active |
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Manufacturer
- Manufacturer
- Chrono-Log Corp
- FDA Applicant
- Chrono-Log Corp.
Sources (2)
- FDA 510(k) K922800 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026