510(k) K790864

RABBIT ANTISERUM TO HUMAN CHORIONIC by Pcl-Ria, Inc. — Product Code JHI

K790864 is an FDA 510(k) premarket notification submitted by Pcl-Ria, Inc. for the device "RABBIT ANTISERUM TO HUMAN CHORIONIC". The FDA issued a decision of Substantially Equivalent on July 17, 1979. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Pcl-Ria, Inc. has at least 10 other 510(k) clearances on record.