WELLCOLEX E-COLI OI57 ZC60

Antisera, All Types, Escherichia Coli

MUREX DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Murex Diagnostics, Inc. with the FDA for Wellcolex E-coli Oi57 Zc60.

Pre-market Notification Details

Device IDK962028
510k NumberK962028
Device Name:WELLCOLEX E-COLI OI57 ZC60
ClassificationAntisera, All Types, Escherichia Coli
Applicant MUREX DIAGNOSTICS, INC. 3705 NORTHWOODS CIRCLE Norcross,  GA  30071
ContactKen Shockley, Ph.d.
CorrespondentKen Shockley, Ph.d.
MUREX DIAGNOSTICS, INC. 3705 NORTHWOODS CIRCLE Norcross,  GA  30071
Product CodeGNA  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-23
Decision Date1996-11-01

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