510(k) K822941

NETILMICIN FLUORESCENT IMMUNOASSAY by American Diagnostic Corp. — Product Code LCE

K822941 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "NETILMICIN FLUORESCENT IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on October 26, 1982. The device falls under product code LCE (Radioimmunoassay, Netilmicin (I-125)), a Class II device regulated under 21 CFR 862.3450. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.