FDA 510(k) Applications for Medical Device Product Code "DJP"
(Radioimmunoassay, Amphetamine)

FDA 510(k) Number Applicant Device Name Decision Date
K882228 DIAGNOSTIC PRODUCTS CORP. REVISED DOUBLE ANTIBODY AMPHETAMINE 08/08/1988
K960526 DIAGNOSTIC REAGENTS, INC. PRIMIDONE EIA TEST 03/18/1996
K823212 HOFFMANN-LA ROCHE, INC. ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE 11/29/1982
K830482 HOFFMANN-LA ROCHE, INC. ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE 03/24/1983
K812986 HOFFMANN-LA ROCHE, INC. AGGLUTEX AMPHETAMINE TEST KIT 01/22/1982
K913866 IMMUNALYSIS CORPORATION URINE AMPHETAMINE DIRECT RIA KIT (I-125) 09/25/1991
K912755 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE 08/26/1991
K854009 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP 10/15/1985
K881817 ROCHE DIAGNOSTIC SYSTEMS, INC. ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES 07/29/1988


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