510(k) K013518

EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM by Irvine Scientific Sales Co., Inc. — Product Code MQL

K013518 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM". The FDA issued a decision of Substantially Equivalent on January 18, 2002. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Irvine Scientific Sales Co., Inc. has at least 10 other 510(k) clearances on record.