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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name trichomonas vaginalis nucleic acid amplification test system
510(k) Number K143329
Device Name AmpliVue Trichomonas Assay
Applicant
QUIDEL CORPORATION
2005 EAST STATE STREET
SUITE 100
ATHENS,  OH  45701
Applicant Contact RONALD H LOLLAR
Correspondent
QUIDEL CORPORATION
2005 EAST STATE STREET
SUITE 100
ATHENS,  OH  45701
Correspondent Contact RONALD H LOLLAR
Regulation Number866.3860
Classification Product Code
OUY  
Date Received11/20/2014
Decision Date 03/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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