510(k) K802461

ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT by Immunotech Corp. — Product Code LCW

K802461 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code LCW (Radioimmunoassay, Digitoxin (125-I)), a Class II device regulated under 21 CFR 862.3300. Immunotech Corp. has at least 10 other 510(k) clearances on record.