510(k) K850386

SYSTEM 8000 CELL COUNTER by Baker Instructions Corp. — Product Code GKL

K850386 is an FDA 510(k) premarket notification submitted by Baker Instructions Corp. for the device "SYSTEM 8000 CELL COUNTER". The FDA issued a decision of Substantially Equivalent on May 2, 1985. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Baker Instructions Corp. has at least 9 other 510(k) clearances on record.