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FDA 510(k)

Trak Male Fertility Testing System

K-Number: K153683 · 2016-05-16

ApplicantSandstone Diagnostics, Inc.
Decision Date2016-05-16
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Trak Male Fertility Testing System is a medical device manufactured by Sandstone Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-05-16 under approval number K153683. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

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. It is manufactured by Sandstone Diagnostics, Inc.. The 510(k) number is K153683.

When was Trak Male Fertility Testing System approved by the FDA?

Trak Male Fertility Testing System received FDA 510(k) clearance on 2016-05-16, under approval number K153683.

What company makes Trak Male Fertility Testing System?

Trak Male Fertility Testing System is manufactured by Sandstone Diagnostics, Inc..

What is the FDA product code for Trak Male Fertility Testing System?

The FDA product code for Trak Male Fertility Testing System is POV.

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Related PubMed Literature

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Other Devices by Sandstone Diagnostics, Inc.

K172514Trak Plus Male Fertility Testing System

Related Devices (Code: POV)

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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.

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