COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit— 510(k) K143724

Name: FDA 510(k) clearance K143724
Creator: U.S. Food and Drug Administration
Published: 2015-08-27

Substantially Equivalent

William A. Cook Australia Pty. , Ltd.

FDA 510(k) clearance K143724 for COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit, Substantially Equivalent on 2015-08-27. Applicant: William A. Cook Australia Pty. , Ltd.. Device class: 2.

Clearance details

Applicant: William A. Cook Australia Pty. , Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2014-12-29
Decision date: 2015-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Brisbane, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQL

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