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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 K122062
Device Name APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
Applicant
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO,  CA  92121 -4362
Applicant Contact MARIA CARMELITA S BALUYOT
Correspondent
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO,  CA  92121 -4362
Correspondent Contact MARIA CARMELITA S BALUYOT
Regulation Number866.3860
Classification Product Code
OUY  
Date Received07/13/2012
Decision Date 01/09/2013
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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