510(k) K871498

TITAN GEL IMMUNOFIX CONTROLS by Helena Laboratories — Product Code DFT

K871498 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITAN GEL IMMUNOFIX CONTROLS". The FDA issued a decision of Substantially Equivalent on April 29, 1987. The device falls under product code DFT (Igm, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Helena Laboratories has at least 10 other 510(k) clearances on record.