510(k) K072607

LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT by Irvine Scientific Sales Co., Inc. — Product Code MQL

K072607 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT". The FDA issued a decision of Substantially Equivalent on January 25, 2008. 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.