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FDA 510(k)

RHEUMATOID FACTOR REFERENCE PREPARA.

K-Number: K821941 · 1982-08-27

ApplicantArmkel, LLC
Decision Date1982-08-27
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMATOID FACTOR REFERENCE PREPARA. is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1982-08-27 under 510(k) number K821941. 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 REFERENCE PREPARA.?

RHEUMATOID FACTOR REFERENCE PREPARA. is a medical device that received FDA 510(k) clearance on 1982-08-27. The listed applicant is Armkel, LLC. The 510(k) number is K821941.

When did RHEUMATOID FACTOR REFERENCE PREPARA. receive FDA 510(k) clearance?

RHEUMATOID FACTOR REFERENCE PREPARA. received FDA 510(k) clearance on 1982-08-27, under 510(k) number K821941.

Who is the listed applicant for RHEUMATOID FACTOR REFERENCE PREPARA.?

The FDA 510(k) record lists Armkel, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RHEUMATOID FACTOR REFERENCE PREPARA.?

The FDA product code for RHEUMATOID FACTOR REFERENCE PREPARA. 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.

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