Thor Henostatsis Analyzer Cat. No. 1450, 1451
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K961908 FDA 510(k)
- FDA Product Code
- JPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5425 FDA 510(k)
- Regulation Number
- 864.5425 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Thor Henostasis Analyzer Cat. No. 1450, 1451 is a multipurpose system for in vitro coagulation studies, classified as a Class II device under FDA regulations. It consists of an automated or semiautomated instrument designed to perform a series of coagulation studies and coagulation factor assays, enabling precise measurement of blood clotting parameters.
This device is intended for use in clinical hematology laboratories and has received FDA 510(k) clearance under the product code JPA. Supplied as a reusable instrument with associated reagents and controls, it adheres to regulatory standards outlined in § 864.5425. The system requires proper calibration and maintenance in accordance with manufacturer guidelines to ensure accurate and reliable coagulation testing.
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: Thor Henostatsis Analyzer Cat. No. 1450, 1451, K961908 FDA 510(k) - THOR HENOSTATSIS ANALYZER CAT. NO. 1450, THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 by HELENA LABORATORIES ..., THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 510 (k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961908 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K961908 24 fields · synced Sep 19, 2026