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FDA 510(k)

RHEUMATOID FACTORS REFERENCE SERUM

K-Number: K810404 · 1981-03-11

ApplicantCalbiochem-Behring Corp.
Decision Date1981-03-11
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMATOID FACTORS REFERENCE SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810404. 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 FACTORS REFERENCE SERUM?

RHEUMATOID FACTORS REFERENCE SERUM is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K810404.

When did RHEUMATOID FACTORS REFERENCE SERUM receive FDA 510(k) clearance?

RHEUMATOID FACTORS REFERENCE SERUM received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810404.

Who is the listed applicant for RHEUMATOID FACTORS REFERENCE SERUM?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RHEUMATOID FACTORS REFERENCE SERUM?

The FDA product code for RHEUMATOID FACTORS REFERENCE SERUM 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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