ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT

Mycoplasma Pneumoniae Dna Assay System

MERIDIAN BIOSCIENCE, INC.

The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Illumigene Mycoplasama Dna Amplification Assay, And Illumigene Mycoplasma External Controls Kit.

Pre-market Notification Details

Device IDK123423
510k NumberK123423
Device Name:ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
ClassificationMycoplasma Pneumoniae Dna Assay System
Applicant MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DRIVE Cincinnati,  OH  45244
ContactMichelle L Smith
CorrespondentMichelle L Smith
MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DRIVE Cincinnati,  OH  45244
Product CodeOZX  
CFR Regulation Number866.3980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-06
Decision Date2013-06-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733101175 K123423 000

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