510(k) K935720

ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM by Ortho Diagnostic Systems, Inc. — Product Code GKZ

K935720 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 1996. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.