FEBRILE ANTIGEN KIT

Antigens (febrile), Agglutination, Brucella Spp.

OXOID U.S.A., INC.

The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Febrile Antigen Kit.

Pre-market Notification Details

Device IDK822663
510k NumberK822663
Device Name:FEBRILE ANTIGEN KIT
ClassificationAntigens (febrile), Agglutination, Brucella Spp.
Applicant OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGSO  
CFR Regulation Number866.3085 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-03
Decision Date1982-09-21

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