FDA 510(k) Applications for Medical Device Product Code "DLP"
(Radioimmunoassay, Diphenylhydantoin)

FDA 510(k) Number Applicant Device Name Decision Date
K770779 AMERSHAM CORP. PHENYTOIN RIA KIT 06/17/1977
K792640 BIO-RAD FLUOROMATIC PHENYTOIN FIA 01/11/1980
K894527 COLONY LABORATORIES, INC. FPR PHENYTOIN KIT 09/25/1989
K811775 KALLESTAD LABORATORIES, INC. KALLESTAD ANTISERA TO PHENYTOIN 07/10/1981
K791896 VENTREX LABORATORIES, INC. CENTRIA PHENYTOIN RIA TEST SET 10/17/1979


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