FDA 510(k) Applications for Medical Device Product Code "DDF"
(Prothrombin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K812985 HOFFMANN-LA ROCHE, INC. AGGLUTEX MORPHINE TEST KIT 12/31/1981
K910617 ORGANON TEKNIKA CORP. NATIVE PROTHROMBIN ANTIGEN EIA 05/15/1991


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