510(k) K891683

TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER by Helena Laboratories — Product Code CZN

K891683 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER". The FDA issued a decision of Substantially Equivalent on April 12, 1989. The device falls under product code CZN (Iga, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Helena Laboratories has at least 10 other 510(k) clearances on record.