510(k) K991070

COULTER Z2 ANALYZER by Coulter Corp. — Product Code GKL

K991070 is an FDA 510(k) premarket notification submitted by Coulter Corp. for the device "COULTER Z2 ANALYZER". The FDA issued a decision of Substantially Equivalent on May 11, 1999. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Coulter Corp. has at least 10 other 510(k) clearances on record.