510(k) K823062

KENAMYCIN FLUORESCENT IMMUNOASSAY FIA by American Diagnostic Corp. — Product Code KJI

K823062 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "KENAMYCIN FLUORESCENT IMMUNOASSAY FIA". The FDA issued a decision of Substantially Equivalent on November 10, 1982. The device falls under product code KJI (Radioimmunoassay, Kanamycin), a Class II device regulated under 21 CFR 862.3520. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.