510(k) K153683
K153683 is an FDA 510(k) premarket notification submitted by Sandstone Diagnostics, Inc. for the device "Trak Male Fertility Testing System". The FDA issued a decision of Substantially Equivalent on May 16, 2016. The device falls under product code POV (Semen Analysis Device), a Class II device regulated under 21 CFR 864.5220. Sandstone Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2016
- Date Received
- December 22, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Semen Analysis Device
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type
Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.