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Automated Rheumatoid Factor Test

by Bd Becton Dickinson Vacutainer Systems Preanalytic

510(k) K800268

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800268 Date21 Feb 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Automated Rhematoid Factor Test (Arft)
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

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Automated Rheumatoid Factor Test is a system designed for the detection of rheumatoid factor. It functions as an immunological test system used to identify these specific antibodies in clinical samples.

This device is classified as a class 2 medical device under regulation 866.5775. It has received FDA 510(k) clearance under the submission number K800268.

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