Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium— 510(k) K153290

Substantially Equivalent

William A. Cook Australia Pty. , Ltd.

FDA 510(k) clearance K153290 for Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium, Substantially Equivalent on 2016-01-27. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Eight Mile Plains, AU
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