FDA 510(k) Application Details - K172514

Device Classification Name	More FDA Info for this Device
510(K) Number	K172514
Device Name	Trak Plus 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	Ulrich Schaff 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	08/21/2017
Decision Date	11/17/2017
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