FDA 510(k) Applications for Medical Device Product Code "DKN"
(Radioimmunoassay, Barbiturate)

FDA 510(k) Number Applicant Device Name Decision Date
K830479 HOFFMANN-LA ROCHE, INC. ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE 03/10/1983
K812988 HOFFMANN-LA ROCHE, INC. AGGLUTEX BARBITURATES TEST KIT 12/31/1981
K914468 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES 10/30/1991
K881816 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES 07/28/1988


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