APTIMA TRICHOMONAS VAGINALIS ASSAY – PANTHER


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

Correspodent Contact maria carmelita s baluyot
Regulation Number 866.3860
Classification Product Code
OUY  
Date Received 07/13/2012
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