Cleared Traditional

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

K161261 · Genea Biomedx Pty, Ltd. · Obstetrics & Gynecology
May 2017
Decision
373d
Days
Class 2
Risk

About This 510(k) Submission

K161261 is an FDA 510(k) clearance for the Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Genea Biomedx Pty, Ltd. (Sydney, AU). The FDA issued a Cleared decision on May 12, 2017, 373 days after receiving the submission on May 4, 2016. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K161261 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2016
Decision Date May 12, 2017
Days to Decision 373 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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