STAPHYLASE TEST

Staphylococcus Aureus Somatic Antigens

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 Staphylase Test.

Pre-market Notification Details

Device IDK874303
510k NumberK874303
Device Name:STAPHYLASE TEST
ClassificationStaphylococcus Aureus Somatic Antigens
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 CodeLHT  
CFR Regulation Number866.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-20
Decision Date1987-11-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384013135 K874303 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.