Identifiers
- 510(k) Number
- K771940 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 Quantrols Rf is a rheumatoid factor test system. It is designed to function as a diagnostic tool for the detection of rheumatoid factor in clinical samples.
This device is manufactured by Organon, Inc. and has received FDA 510(k) clearance under the regulation number 866.5775.
Frequently asked questions
What is the primary purpose of the Quantrols Rf system?
The Quantrols Rf is a diagnostic tool specifically designed for the detection of rheumatoid factor within clinical samples to assist in laboratory testing.
Has this device received regulatory clearance?
Yes, the Quantrols Rf has received FDA 510(k) clearance under regulation number 866.5775, confirming it has been reviewed as a substantially equivalent device.
Who is the manufacturer of this rheumatoid factor test system?
The Quantrols Rf system is manufactured by Organon, Inc., which is based in McHenry, Illinois.
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: QUANTROLS RF (K771940) — FDA 510 (k) | Innolitics, Quantrols Rf 510 (k) FDA Premarket Notification K771940 ORGANON, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K771940 | Class II | Active |
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Manufacturer
- Manufacturer
- Organon, Inc.
Sources (1)
- FDA 510(k) K771940 24 fields · synced Sep 26, 2026