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 |