IMMUNOCARD STAT! EHEC, MODEL 751630

Antigens, All Types, Escherichia Coli

MERIDIAN BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Immunocard Stat! Ehec, Model 751630.

Pre-market Notification Details

Device IDK062546
510k NumberK062546
Device Name:IMMUNOCARD STAT! EHEC, MODEL 751630
ClassificationAntigens, All Types, Escherichia Coli
Applicant MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactSusan Rolih
CorrespondentSusan Rolih
MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
Product CodeGMZ  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-30
Decision Date2007-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733101366 K062546 000

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