The following data is part of a premarket notification filed by Sandstone Diagnostics, Inc. with the FDA for Trak Plus Male Fertility Testing System.
| Device ID | K172514 |
| 510k Number | K172514 |
| Device Name: | Trak Plus Male Fertility Testing System |
| Classification | Semen Analysis Device |
| Applicant | Sandstone Diagnostics, Inc. 6111 Southfront Road, Suite J Livermore, CA 94551 |
| Contact | Ulrich Schaff |
| Correspondent | Ulrich Schaff Sandstone Diagnostics, Inc. 6111 Southfront Road, Suite J Livermore, CA 94551 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2017-11-17 |
| Summary: | summary |