510(k) K061970

ELECSYS IGE II IMMUNOASSAY by Roche Diagnostics — Product Code JHR

K061970 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS IGE II IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on August 31, 2006. The device falls under product code JHR (Radioimmunoassay, Immunoglobulins (D, E)), a Class II device regulated under 21 CFR 866.5510. Roche Diagnostics has at least 10 other 510(k) clearances on record.