FDA 510(k) Applications for Medical Device Product Code "DIW"
(Hemagglutination Inhibition, Methadone)

FDA 510(k) Number Applicant Device Name Decision Date
K950182 E.I. DUPONT DE NEMOURS & CO., INC. URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE 03/21/1995
K760075 J.T. BAKER CHEMICAL CO. KIT, METHADONE (TOXI-PAK IMMUNO HI) 07/20/1976
K930845 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE ABUSCREEN ONTRAK FOR METHADONE 04/20/1993
K801509 TECHNAM, INC. HI-M-TEST FOR METHADONE TEST #2 07/14/1980


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