510(k) K160006

Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit by Irvine Scientific — Product Code MQL

K160006 is an FDA 510(k) premarket notification submitted by Irvine Scientific for the device "Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit". The FDA issued a decision of Substantially Equivalent on May 4, 2016. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Irvine Scientific has at least 10 other 510(k) clearances on record.