FDA 510(k) Applications for Medical Device Product Code "DGP"
(Ige, Fitc, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K842969 ALLERGENETICS ALLERGENETICS ALLER-SPECIFIC IGE SERUM 08/28/1984
K931224 BIOMERIEUX VITEK, INC. VIDAS TOTAL IGE (IGE) ASSAY 05/20/1993
K842749 INTL. DIAGNOSTIC TECHNOLOGY FIAX TOTAL IGE TEST KIT 08/28/1984
K863327 SCLAVO, INC. IMMPULSE IGE ASSAY REAGENTS 12/03/1986


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