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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 K133503
Device Name AMPLIVUE GBS ASSAY
Applicant
QUIDEL CORPORATION
2005 EAST STATE ST., SUITE 100
ATHENS,  OH  45701
Applicant Contact Ronald H Lollar
Correspondent
QUIDEL CORPORATION
2005 EAST STATE ST., SUITE 100
ATHENS,  OH  45701
Correspondent Contact Ronald H Lollar
Regulation Number866.3740
Classification Product Code
NJR  
Date Received11/14/2013
Decision Date 12/20/2013
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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