FDA 510(k) Applications for Medical Device Product Code "JHR"
(Radioimmunoassay, Immunoglobulins (D, E))

FDA 510(k) Number Applicant Device Name Decision Date
K984326 BOEHRINGER MANNHEIM CORP. ELECYS IGE ASSAY 02/08/1999
K960067 DIAGNOSTIC PRODUCTS CORP. IMMILITE TOTAL IGE 02/14/1996
K061970 Roche Diagnostics ELECSYS IGE II IMMUNOASSAY 08/31/2006


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