PREMIER EHEC

Antisera, All Types, Escherichia Coli

MERIDIAN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Premier Ehec.

Pre-market Notification Details

Device IDK953362
510k NumberK953362
Device Name:PREMIER EHEC
ClassificationAntisera, All Types, Escherichia Coli
Applicant MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactAllen D Nickol
CorrespondentAllen D Nickol
MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
Product CodeGNA  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-17
Decision Date1995-11-14

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