The following data is part of a premarket notification filed by Sandstone Diagnostics, Inc. with the FDA for Trak Male Fertility Testing System.
Device ID | K153683 |
510k Number | K153683 |
Device Name: | Trak Male Fertility Testing System |
Classification | Semen Analysis Device |
Applicant | SANDSTONE DIAGNOSTICS, INC. 6111 SOUTHFRONT ROAD, SUITE J Livermore, CA 94551 |
Contact | Greg Sommer |
Correspondent | Erika Ammirati AMMIRATI REGULATORY CONSULTING 575 SHIRLYNN COURT Los Altos, CA 94022 |
Product Code | POV |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-12-22 |
Decision Date | 2016-05-16 |
Summary: | summary |