510(k) K781070

SECOND ANTIBODY by Pcl-Ria, Inc. — Product Code KTS

K781070 is an FDA 510(k) premarket notification submitted by Pcl-Ria, Inc. for the device "SECOND ANTIBODY". The FDA issued a decision of Substantially Equivalent on August 10, 1978. The device falls under product code KTS (Second Antibody (Species Specific Anti-Animal Gamma Globulin)), a Class II device regulated under 21 CFR 866.5510. Pcl-Ria, Inc. has at least 10 other 510(k) clearances on record.