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FDA 510(k)

RHEUMATOID FACTOR TEST SYSTEMS

K-Number: K802688 · 1980-12-18

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1980-12-18
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMATOID FACTOR TEST SYSTEMS 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 1980-12-18 under 510(k) number K802688. 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 RHEUMATOID FACTOR TEST SYSTEMS?

RHEUMATOID FACTOR TEST SYSTEMS is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K802688.

When did RHEUMATOID FACTOR TEST SYSTEMS receive FDA 510(k) clearance?

RHEUMATOID FACTOR TEST SYSTEMS received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802688.

Who is the listed applicant for RHEUMATOID FACTOR TEST SYSTEMS?

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 RHEUMATOID FACTOR TEST SYSTEMS?

The FDA product code for RHEUMATOID FACTOR TEST SYSTEMS is DHR.

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Related Devices (Code: DHR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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