510(k) K900422

TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 by Helena Laboratories — Product Code CZP

K900422 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046". The FDA issued a decision of Substantially Equivalent on February 27, 1990. The device falls under product code CZP (Iga, 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.