510(k) K874054

FISHER DIAGNOSTICS HEMATALL III LAS REAGENT by Fisher Scientific Co., LLC — Product Code GGK

K874054 is an FDA 510(k) premarket notification submitted by Fisher Scientific Co., LLC for the device "FISHER DIAGNOSTICS HEMATALL III LAS REAGENT". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Fisher Scientific Co., LLC has at least 10 other 510(k) clearances on record.