YO Home Sperm Test— 510(k) K161493

Substantially Equivalent

Medical Electronic Systems , Ltd.

FDA 510(k) clearance K161493 for YO Home Sperm Test, Substantially Equivalent on 2016-11-08. Applicant: Medical Electronic Systems , Ltd..

Clearance details

Applicant: Medical Electronic Systems , Ltd.
Product code: Code POV
Advisory panel: Hematology
Date received: 2016-06-01
Decision date: 2016-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea Ind. Park, IL

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