FDA 510(k)

COCCIDIOIDES LATEX AGGLUTINATION

K-Number: K812189 · 1981-08-25

Decision Date1981-08-25

Product CodeGMG

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

COCCIDIOIDES LATEX AGGLUTINATION is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1981-08-25 under 510(k) number K812189. The device is classified under product code GMG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COCCIDIOIDES LATEX AGGLUTINATION?

COCCIDIOIDES LATEX AGGLUTINATION is a medical device that received FDA 510(k) clearance on 1981-08-25. The listed applicant is American Scientific Products. The 510(k) number is K812189.

When did COCCIDIOIDES LATEX AGGLUTINATION receive FDA 510(k) clearance?

COCCIDIOIDES LATEX AGGLUTINATION received FDA 510(k) clearance on 1981-08-25, under 510(k) number K812189.

Who is the listed applicant for COCCIDIOIDES LATEX AGGLUTINATION?

The FDA 510(k) record lists American Scientific Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COCCIDIOIDES LATEX AGGLUTINATION?

The FDA product code for COCCIDIOIDES LATEX AGGLUTINATION is GMG.

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Related Devices (Code: GMG)

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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.