FDA 510(k) Applications for Medical Device Product Code "DOE"
(Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.)

FDA 510(k) Number Applicant Device Name Decision Date
K010080 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST 05/29/2001
K010079 ALFA SCIENTIFIC DESIGNS, INC. INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST 05/29/2001
K002418 BRANAN MEDICAL CORPORATION BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D 11/22/2000
K863913 DIAGNOSTIC PRODUCTS CORP. THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT 03/19/1987
K830460 HOFFMANN-LA ROCHE, INC. ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE 03/24/1983
K830462 HOFFMANN-LA ROCHE, INC. ABUSCREEN RADIOUMMUNOASSAY--URINE 03/24/1983
K881102 ICN MICROMEDIC SYSTEMS MICROMEDIC MORPHINE RIA KIT 06/24/1988
K933572 IMMUNALYSIS CORPORATION URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) 04/06/1994
K011011 PAN PROBE BIOTECH, INC. LIVESURE MORPHINE SCREEN TEST 04/13/2001
K864168 ROCHE DIAGNOSTIC SYSTEMS, INC. MORPHINE ROCHE (R) EIA TEST 03/16/1987
K951319 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION 06/01/1995
K935055 ROCHE DIAGNOSTIC SYSTEMS, INC. ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) 08/09/1994


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact