510(k) K152782

SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT by William A. Cook Australia Pty. , Ltd. — Product Code MQL

K152782 is an FDA 510(k) premarket notification submitted by William A. Cook Australia Pty. , Ltd. for the device "SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT". The FDA issued a decision of Substantially Equivalent on December 21, 2015. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. William A. Cook Australia Pty. , Ltd. has at least 10 other 510(k) clearances on record.