Trak Male Fertility Testing System
K-Number: K153683 · 2016-05-16
Device Summary
Frequently Asked Questions
What is the Trak Male Fertility Testing System?
Trak Male Fertility Testing System is a medical device that received FDA 510(k) clearance on 2016-05-16. The listed applicant is Sandstone Diagnostics, Inc.. The 510(k) number is K153683.
When did Trak Male Fertility Testing System receive FDA 510(k) clearance?
Trak Male Fertility Testing System received FDA 510(k) clearance on 2016-05-16, under 510(k) number K153683.
Who is the listed applicant for Trak 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 Male Fertility Testing System?
The FDA product code for Trak 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.