Cleared Special

COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit

K143724 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
Aug 2015
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K143724 is an FDA 510(k) clearance for the COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by William A. Cook Australia Pty. , Ltd. (Brisbane, AU). The FDA issued a Cleared decision on August 27, 2015, 241 days after receiving the submission on December 29, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K143724 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2014
Decision Date August 27, 2015
Days to Decision 241 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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