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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
Device Name ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DR.
CINCINNATI,  OH  45244
Applicant Contact SUSAN D ROLIH
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DR.
CINCINNATI,  OH  45244
Correspondent Contact SUSAN D ROLIH
Regulation Number866.3740
Classification Product Code
NJR  
Date Received07/25/2011
Decision Date 12/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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