HEP-TROL Partial Thromboplastin Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K801932 FDA 510(k)
- FDA Product Code
- GGW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7925 FDA 510(k)
- Regulation Number
- 864.7925 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HEP-TROL is a Test, Time, Partial Thromboplastin device, classified under hematology diagnostics. It is designed to measure activated partial thromboplastin time (aPTT), a critical coagulation assay used to evaluate blood clotting function and monitor patients on anticoagulant therapy such as heparin.
This device is supplied as a single-use diagnostic reagent, intended for use in clinical laboratories and hematology settings. It is regulated under FDA 510(k) clearance (K801932) and falls under Regulation 864.7925, adhering to Class II special controls. No MRI safety or sterility specifications are noted in the regulatory data.
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: HEP-TROL (K801932) — FDA 510 (k) | Innolitics, K801932 FDA 510(k) - HEP-TROL | Helena Laboratories, Hep-trol 510 (k) K801932 - FDA.report, PDF K801932 - Hep-trol
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K801932 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K801932 24 fields · synced Oct 1, 2026