510(k) K061979

MODIFICATION TO MYALLERGY TEST by Immunetech Corporation — Product Code JKA

K061979 is an FDA 510(k) premarket notification submitted by Immunetech Corporation for the device "MODIFICATION TO MYALLERGY TEST". The FDA issued a decision of Substantially Equivalent on September 22, 2006. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Immunetech Corporation has at least 3 other 510(k) clearances on record.