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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K153683
Device Name Trak Male Fertility Testing System
Applicant
SANDSTONE DIAGNOSTICS, INC.
6111 SOUTHFRONT ROAD, SUITE J
LIVERMORE,  CA  94551
Applicant Contact Greg Sommer
Correspondent
AMMIRATI REGULATORY CONSULTING
575 SHIRLYNN COURT
LOS ALTOS,  CA  94022
Correspondent Contact Erika Ammirati
Regulation Number864.5220
Classification Product Code
POV  
Date Received12/22/2015
Decision Date 05/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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