FDA 510(k) Applications for Medical Device Product Code "DGE"
(Igd, Rhodamine, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K871972 AMERICAN DADE STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY 07/21/1987
K915838 PB DIAGNOSTIC SYSTEMS, INC. OPUS FERRITIN TEST SYSTEM 03/18/1992


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