510(k) K864664

H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS by Technicon Instruments Corp. — Product Code KSA

K864664 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS". The FDA issued a decision of Substantially Equivalent on February 6, 1987. The device falls under product code KSA (Calibrator For Red-Cell And White-Cell Counting), a Class II device regulated under 21 CFR 864.8185. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.