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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name group a streptococcus nucleic acid amplification assay system
510(k) Number K122019
Models 279910, 280150
Device Name STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
Original Applicant
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati,  OH  45244
Original Contact michelle l smith
Regulation Number866.3740
Classification Product Code
OYZ  
Subsequent Product Code
OOI  
Date Received07/10/2012
Decision Date 09/13/2012
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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