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FDA 510(k)

FEBRILE ANTIGEN KIT

K-Number: K822663 · 1982-09-21

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

Device Summary

FEBRILE ANTIGEN KIT 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 K822663. The device is classified under product code GSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEBRILE ANTIGEN KIT?

FEBRILE ANTIGEN KIT 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 K822663.

When did FEBRILE ANTIGEN KIT receive FDA 510(k) clearance?

FEBRILE ANTIGEN KIT received FDA 510(k) clearance on 1982-09-21, under 510(k) number K822663.

Who is the listed applicant for FEBRILE ANTIGEN KIT?

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 FEBRILE ANTIGEN KIT?

The FDA product code for FEBRILE ANTIGEN KIT is GSO.

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Other records listing Oxoid U.S.A., Inc. as applicant

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.

K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMK884026ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KITK884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)K874303STAPHYLASE TESTK872956SORBITOL MACCONKEY AGAR NO. 3 CM 813K872135MCBRIDE MEDIUM CM 819

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Related Devices (Code: GSO)

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.

K972396VISTA ANTIGEN BRUCELLA MELITENSISLee Laboratories, Inc.K972394VISTA ANTIGEN BRUCELLA ABORTUSLee Laboratories, Inc.K952139SAS BRUCELLA SUIS ANTIGENSa Scientific, Inc.K952147SAS BRUCELLA ABORTUS ANTIGENSa Scientific, Inc.K952131SAS FEBRILE ANTIGEN SETSa Scientific, Inc.K952135SAS SALMONELLA H D ANTIGENSa Scientific, Inc.

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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