FDA 510(k)

AUTOMATED RHEMATOID FACTOR TEST (ARFT)

K-Number: K800268 · 1980-02-21

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1980-02-21

Product CodeDHR

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

AUTOMATED RHEMATOID FACTOR TEST (ARFT) is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1980-02-21 under 510(k) number K800268. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED RHEMATOID FACTOR TEST (ARFT)?

AUTOMATED RHEMATOID FACTOR TEST (ARFT) is a medical device that received FDA 510(k) clearance on 1980-02-21. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K800268.

When did AUTOMATED RHEMATOID FACTOR TEST (ARFT) receive FDA 510(k) clearance?

AUTOMATED RHEMATOID FACTOR TEST (ARFT) received FDA 510(k) clearance on 1980-02-21, under 510(k) number K800268.

Who is the listed applicant for AUTOMATED RHEMATOID FACTOR TEST (ARFT)?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATED RHEMATOID FACTOR TEST (ARFT)?

The FDA product code for AUTOMATED RHEMATOID FACTOR TEST (ARFT) is DHR.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.