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

Name: FDA 510(k) clearance K161261
Creator: U.S. Food and Drug Administration
Published: 2017-05-12

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.. Device class: 2.

Clearance details

Applicant: Genea Biomedx Pty, Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2016-05-04
Decision date: 2017-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.