DRYSPOT E.COLI 0157 KIT

Antisera, All Types, Escherichia Coli

OXOID, LTD.

The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Dryspot E.coli 0157 Kit.

Pre-market Notification Details

Device IDK993401
510k NumberK993401
Device Name:DRYSPOT E.COLI 0157 KIT
ClassificationAntisera, All Types, Escherichia Coli
Applicant OXOID, LTD. WADE RD. Basingstoke, Hampshire,  GB Rg24 8pw
ContactAmanda Sheppard
CorrespondentAmanda Sheppard
OXOID, LTD. WADE RD. Basingstoke, Hampshire,  GB Rg24 8pw
Product CodeGNA  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-08
Decision Date2000-02-28

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