OXOID STREPTOCOCAL GROUPING KIT

Antisera, All Groups, Streptococcus 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 Oxoid Streptococal Grouping Kit.

Pre-market Notification Details

Device IDK854929
510k NumberK854929
Device Name:OXOID STREPTOCOCAL GROUPING KIT
ClassificationAntisera, All Groups, Streptococcus Spp.
Applicant OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia,  MD  21045
ContactRuth Kemp
CorrespondentRuth Kemp
OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia,  MD  21045
Product CodeGTZ  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-10
Decision Date1986-03-11

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