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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nucleic acid amplification assay system, group b streptococcus, direct specimen test
510(k) Number K112125
Models 208350,279900, 610172
Device Name ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
Original Applicant
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati,  OH  45244
Original Contact susan d rolih
Regulation Number866.3740
Classification Product Code
NJR  
Date Received07/25/2011
Decision Date 12/05/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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