IMMUNOCARD STAT! E. COLI O157 PLUS

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! E. Coli O157 Plus.

Pre-market Notification Details

Device IDK023599
510k NumberK023599
Device Name:IMMUNOCARD STAT! E. COLI O157 PLUS
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 Received2002-10-28
Decision Date2003-01-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733101816 K023599 000

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