Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase— 510(k) K161261

Substantially Equivalent

Genea Biomedx Pty, Ltd.

FDA 510(k) clearance K161261 for Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase, Substantially Equivalent on 2017-05-12. Applicant: Genea Biomedx Pty, Ltd..

Clearance details

Applicant: Genea Biomedx Pty, Ltd.
Product code: Code MQL
Advisory panel: Obstetrics/Gynecology
Date received: 2016-05-04
Decision date: 2017-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

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