510(k) K820324

EMIT AND NETILMICIN ASSAY by Syva Co. — Product Code LCE

K820324 is an FDA 510(k) premarket notification submitted by Syva Co. for the device "EMIT AND NETILMICIN ASSAY". The FDA issued a decision of Substantially Equivalent on February 23, 1982. The device falls under product code LCE (Radioimmunoassay, Netilmicin (I-125)), a Class II device regulated under 21 CFR 862.3450. Syva Co. has at least 10 other 510(k) clearances on record.