510(k) K190152

Vit Kit- Freeze NX and Vit Kit- Warm NX by Fujifilm Irvine Scientific, Inc. — Product Code MQL

K190152 is an FDA 510(k) premarket notification submitted by Fujifilm Irvine Scientific, Inc. for the device "Vit Kit- Freeze NX and Vit Kit- Warm NX". The FDA issued a decision of Substantially Equivalent on June 21, 2019. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Fujifilm Irvine Scientific, Inc. has at least 4 other 510(k) clearances on record.