ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920

C. Difficile Nucleic Acid Amplification Test Assay

MERIDIAN BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene C. Difficile, Illumipro-10 And Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920.

Pre-market Notification Details

Device IDK100818
510k NumberK100818
Device Name:ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
ClassificationC. Difficile Nucleic Acid Amplification Test Assay
Applicant MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactMichelle L Smith
CorrespondentMichelle L Smith
MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
Product CodeOMN  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-23
Decision Date2010-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733101663 K100818 000

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