510(k) K021358

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

K021358 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "EMBRYO BIOPSY MEDIUM". The FDA issued a decision of Substantially Equivalent on July 5, 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.