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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
510(k) Number K141173
Device Name AMPLIVUE GAS ASSAY
Applicant
QUIDEL CORPORATION
2005 E State St Suite 100
ATHENS,  OH  45701
Applicant Contact Ronald H Lollar
Correspondent
QUIDEL CORPORATION
2005 E State St Suite 100
ATHENS,  OH  45701
Correspondent Contact Ronald H Lollar
Regulation Number866.2680
Classification Product Code
PGX  
Date Received05/06/2014
Decision Date 07/24/2014
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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