Identifiers
- 510(k) Number
- K771410 FDA 510(k)
- FDA Product Code
- DHR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5775 FDA 510(k)
- Regulation Number
- 866.5775 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rheumanosticon R is a diagnostic test system designed to detect rheumatoid factor in patient specimens. It is classified as a System, Test for Rheumatoid Factor and is used within the general immunology specialty to support the evaluation of autoimmune conditions.
The device was cleared by the FDA through a traditional 510(k) submission (K771410) and is assigned to product code DHR, class 2. It is manufactured by Organon, Inc. in McHenry, Illinois, United States, and was received for review on 1 August 1977 with clearance granted on 2 September 1977.
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: RHEUMANOSTICON R (K771410) — FDA 510 (k) | Innolitics, Organon Rheumanosticon Dri-Dot (10965) - Rheumatoid factor (RF)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K771410 | Class II | Active |
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Manufacturer
- Manufacturer
- Organon, Inc.
Sources (1)
- FDA 510(k) K771410 24 fields · synced Sep 25, 2026