510(k) K931247

TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 by Helena Laboratories — Product Code DAH

K931247 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067". The FDA issued a decision of Substantially Equivalent on April 27, 1993. The device falls under product code DAH (Gamma Globulin, 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.