510(k) K853036

PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 by Diagnostic Technology, Inc. — Product Code GKL

K853036 is an FDA 510(k) premarket notification submitted by Diagnostic Technology, Inc. for the device "PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1". The FDA issued a decision of Substantially Equivalent on November 5, 1985. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Diagnostic Technology, Inc. has at least 10 other 510(k) clearances on record.