510(k) K042241

K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C by Kamiya Biomedical Co. — Product Code DGC

K042241 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C". The FDA issued a decision of Substantially Equivalent on December 10, 2004. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.