510(k) K152682

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit by Willian A. Cook Australia Pty, Ltd. — Product Code MQL

K152682 is an FDA 510(k) premarket notification submitted by Willian A. Cook Australia Pty, Ltd. for the device "Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit". The FDA issued a decision of Substantially Equivalent on May 5, 2016. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Willian A. Cook Australia Pty, Ltd. has at least 1 other 510(k) clearance on record.