510(k) K942209

LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH by Bio-Rad — Product Code JCN

K942209 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH". The FDA issued a decision of Substantially Equivalent on June 16, 1994. The device falls under product code JCN (Control, Cell Counter, Normal And Abnormal), a Class II device regulated under 21 CFR 864.8625. Bio-Rad has at least 10 other 510(k) clearances on record.