Trak Male Fertility Testing System— 510(k) K153683

Name: FDA 510(k) clearance K153683
Creator: U.S. Food and Drug Administration
Published: 2016-05-16

Substantially Equivalent

Sandstone Diagnostics, Inc.

FDA 510(k) clearance K153683 for Trak Male Fertility Testing System, Substantially Equivalent on 2016-05-16. Applicant: Sandstone Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sandstone Diagnostics, Inc.
Product code: Code POV
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2015-12-22
Decision date: 2016-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Livermore, CA, US

Download summary PDF View on FDA.gov ↗

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