About This 510(k) Submission
K152782 is an FDA 510(k) clearance for the SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on December 21, 2015, 87 days after receiving the submission on September 25, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.