510(k) K170681

Continuous Single Culture -NX (CSCM-NX) by Irvine Scientific Sales Co., Inc. — Product Code MQL

K170681 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "Continuous Single Culture -NX (CSCM-NX)". The FDA issued a decision of Substantially Equivalent on June 8, 2017. 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.