510(k) K133404

IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH by Phadia AB — Product Code DGC

K133404 is an FDA 510(k) premarket notification submitted by Phadia AB for the device "IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH". The FDA issued a decision of Substantially Equivalent on February 24, 2014. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Phadia AB has at least 10 other 510(k) clearances on record.