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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
Device Name STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DR.
CINCINNATI,  OH  45244
Applicant Contact Michelle L Smith
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 RIVER HILLS DR.
CINCINNATI,  OH  45244
Correspondent 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 (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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