510(k) K933475

TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 by Miles, Inc. — Product Code GKZ

K933475 is an FDA 510(k) premarket notification submitted by Miles, Inc. for the device "TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11". The FDA issued a decision of Substantially Equivalent on November 22, 1993. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Miles, Inc. has at least 10 other 510(k) clearances on record.