STAPHYTECT-OD

Staphylococcus Aureus Protein A Insoluble

UNIPATH LTD.

The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Staphytect-od.

Pre-market Notification Details

Device IDK940557
510k NumberK940557
Device Name:STAPHYTECT-OD
ClassificationStaphylococcus Aureus Protein A Insoluble
Applicant UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg,  GB
ContactLouise Roberts
CorrespondentLouise Roberts
UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg,  GB
Product CodeLHJ  
CFR Regulation Number866.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-07
Decision Date1994-07-28

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