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Rf

by Abbott Laboratories 510(k)

Active United States

510(k) K990035

Overview

The device is a System, Test, Rheumatoid Factor, used for immunology testing. It is a substantially equivalent device cleared through the traditional 510(k) pathway.

Manufactured by Abbott Laboratories, it is supplied as a reusable system for laboratory use. The device has FDA 510(k) authorization under product code DHR and regulation number 866.5775.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990035 Date8 Mar 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
DHR
Device Class
Class II
Regulation
21 CFR Part 866.5775
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Other devices from Abbott Laboratories

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Questions

  • What is the RF System Test Rheumatoid Factor used for?

    The RF System Test Rheumatoid Factor is used for immunology testing, specifically to detect rheumatoid factor in patient samples as part of laboratory diagnostic procedures.

  • Is the RF System Test Rheumatoid Factor reusable or single-use?

    The device is supplied as a reusable system for laboratory use, meaning it is designed for multiple uses after appropriate cleaning and maintenance between tests.

  • How is the RF System Test Rheumatoid Factor supplied and by whom?

    Manufactured by Abbott Laboratories, the RF System Test Rheumatoid Factor is supplied as a reusable system intended for use in clinical laboratory settings.

  • What regulatory pathway was used for the RF System Test Rheumatoid Factor?

    The device received FDA 510(k) clearance through the traditional pathway, with clearance granted on March 8, 1999, under k-number K990035.

  • What is the product code and regulation number for the RF System Test Rheumatoid Factor?

    The device is classified under product code DHR and regulation number 866.5775, which pertains to immunology testing systems for rheumatoid factor detection.