Trak Plus Male Fertility Testing System
K-Number: K172514 · 2017-11-17
Device Summary
Frequently Asked Questions
What is the Trak Plus Male Fertility Testing System?
Trak Plus Male Fertility Testing System is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Sandstone Diagnostics, Inc.. The 510(k) number is K172514.
When did Trak Plus Male Fertility Testing System receive FDA 510(k) clearance?
Trak Plus Male Fertility Testing System received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172514.
Who is the listed applicant for Trak Plus Male Fertility Testing System?
The FDA 510(k) record lists Sandstone Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Trak Plus Male Fertility Testing System?
The FDA product code for Trak Plus Male Fertility Testing System is POV.
Other records listing Sandstone Diagnostics, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: POV)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.