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FDA 510(k)

REAGIN ANTIGEN SUSPENSION

K-Number: K822662 · 1982-09-21

ApplicantOxoid U.S.A., Inc.
Decision Date1982-09-21
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REAGIN ANTIGEN SUSPENSION is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1982-09-21 under 510(k) number K822662. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGIN ANTIGEN SUSPENSION?

REAGIN ANTIGEN SUSPENSION is a medical device that received FDA 510(k) clearance on 1982-09-21. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K822662.

When did REAGIN ANTIGEN SUSPENSION receive FDA 510(k) clearance?

REAGIN ANTIGEN SUSPENSION received FDA 510(k) clearance on 1982-09-21, under 510(k) number K822662.

Who is the listed applicant for REAGIN ANTIGEN SUSPENSION?

The FDA 510(k) record lists Oxoid U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAGIN ANTIGEN SUSPENSION?

The FDA product code for REAGIN ANTIGEN SUSPENSION is GMQ.

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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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