FDA 510(k) Application Details - K153683

Device Classification Name	More FDA Info for this Device
510(K) Number	K153683
Device Name	Trak Male Fertility Testing System
Applicant	SANDSTONE DIAGNOSTICS, INC. 6111 SOUTHFRONT ROAD, SUITE J LIVERMORE, CA 94551 US Other 510(k) Applications for this Company
Contact	Greg Sommer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2015
Decision Date	05/16/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review