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 |