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DOE — Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. Class II

FDA Device Classification

Classification Details

Product Code
DOE
Device Class
Class II
Regulation Number
862.3640
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K010079alfa scientific designsINSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TESTMay 29, 2001
K010080alfa scientific designsINSTANT-VIEW MORPHINE (2000) URINE CASSETTE TESTMay 29, 2001
K011011pan probe biotechLIVESURE MORPHINE SCREEN TESTApril 13, 2001
K002418branan medical corporationBRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C ANNovember 22, 2000
K951319roche diagnostic systemsROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800June 1, 1995
K935055roche diagnostic systemsROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)August 9, 1994
K933572immunalysis corporationURINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)April 6, 1994
K881102icn micromedic systemsMICROMEDIC MORPHINE RIA KITJune 24, 1988
K863913diagnostic productsTHE DPC COAT-A-COUNT SERUM MORPHINE RIA KITMarch 19, 1987
K864168roche diagnostic systemsMORPHINE ROCHE (R) EIA TESTMarch 16, 1987
K830462hoffmann-la rocheABUSCREEN RADIOUMMUNOASSAY--URINEMarch 24, 1983
K830460hoffmann-la rocheABUSCREEN RADIOIMMUNOASSAY FOR MORPHINEMarch 24, 1983