SYDNEY IVF EMBRYO BIOPSY MEDIUM— 510(k) K152904

Name: FDA 510(k) clearance K152904
Creator: U.S. Food and Drug Administration
Published: 2015-12-03

Substantially Equivalent

William A. Cook Australia Pty. , Ltd.

FDA 510(k) clearance K152904 for SYDNEY IVF EMBRYO BIOPSY MEDIUM, Substantially Equivalent on 2015-12-03. 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: 2015-10-01
Decision date: 2015-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Eight Mile Plains, AU

Download summary PDF View on FDA.gov ↗

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