510(k) K052793

IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02 by Pharmacia Diagnostics AB — Product Code MST

K052793 is an FDA 510(k) premarket notification submitted by Pharmacia Diagnostics AB for the device "IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, 10-9306-02". The FDA issued a decision of Substantially Equivalent on February 7, 2006. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Pharmacia Diagnostics AB has at least 8 other 510(k) clearances on record.