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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 K121044
Model 280350
Device Name ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati,  OH  45244
Contact michelle l smith
Regulation Number866.3740
Classification Product Code
NJR  
Date Received04/06/2012
Decision Date 05/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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