510(k) K882612

SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER by Baker Instructions Corp. — Product Code GKZ

K882612 is an FDA 510(k) premarket notification submitted by Baker Instructions Corp. for the device "SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER". The FDA issued a decision of Substantially Equivalent on September 7, 1988. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Baker Instructions Corp. has at least 9 other 510(k) clearances on record.