Trak Plus Male Fertility Testing System— 510(k) K172514
Substantially EquivalentSandstone Diagnostics, Inc.
FDA 510(k) clearance K172514 for Trak Plus Male Fertility Testing System, Substantially Equivalent on 2017-11-17. Applicant: Sandstone Diagnostics, Inc..
Clearance details
- Applicant
- Sandstone Diagnostics, Inc.
- Product code
- Code POV
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Livermore, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.