Cleared Special

Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit

K152717 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
May 2016
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K152717 is an FDA 510(k) clearance for the Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit, 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 May 6, 2016, 228 days after receiving the submission on September 21, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K152717 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2015
Decision Date May 06, 2016
Days to Decision 228 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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