510(k) K790029

FLUID, RHEMOX W LYSING by Sysmex Corp. — Product Code GGK

K790029 is an FDA 510(k) premarket notification submitted by Sysmex Corp. for the device "FLUID, RHEMOX W LYSING". The FDA issued a decision of Substantially Equivalent on February 26, 1979. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Sysmex Corp. has at least 10 other 510(k) clearances on record.