Cleared Special

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium

K153290 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
Jan 2016
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K153290 is an FDA 510(k) clearance for the Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on January 27, 2016, 75 days after receiving the submission on November 13, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K153290 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2015
Decision Date January 27, 2016
Days to Decision 75 days
Submission Type Special
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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