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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
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