Atlas FDA

DOE

12 FDA 510(k) clearances · Product code

139 daysmedian time to decision
257 days90th percentile
12clearances measured

FDA profile

Official device name
Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3640
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST (K010079)Alfa Scientific Designs, Inc.2001-05-29
INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST (K010080)Alfa Scientific Designs, Inc.2001-05-29
LIVESURE MORPHINE SCREEN TEST (K011011)Pan Probe Biotech, Inc.2001-04-13
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D (K002418)Branan Medical Corporation2000-11-22
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION (K951319)Roche Diagnostic Systems, Inc.1995-06-01
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) (K935055)Roche Diagnostic Systems, Inc.1994-08-09
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) (K933572)Immunalysis Corporation1994-04-06
MICROMEDIC MORPHINE RIA KIT (K881102)Icn Micromedic Systems1988-06-24
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT (K863913)Diagnostic Products Corp.1987-03-19
MORPHINE ROCHE (R) EIA TEST (K864168)Roche Diagnostic Systems, Inc.1987-03-16
ABUSCREEN RADIOUMMUNOASSAY--URINE (K830462)Hoffmann-La Roche, Inc.1983-03-24
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (K830460)Hoffmann-La Roche, Inc.1983-03-24

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Every clearance here is in the API, with alerts when new ones post.