FDA.reportPublic FDA data

510(k) K011011

Device
LIVESURE MORPHINE SCREEN TEST
Applicant
Pan Probe Biotech, Inc.
510(k) number
K011011
Product code
DOE
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-13
Date received
2001-04-04
Regulation
862.3640
Classification name
Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Y

Applicant Contact#

Contact
ALICE H YU
Address
8515 Arjons Dr., Suite A San Diego CA US 92126 92126

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DOE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K010079INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TESTAlfa Scientific Designs, Inc.2001-05-29
K010080INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TESTAlfa Scientific Designs, Inc.2001-05-29
K002418BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133DBranan Medical Corporation2000-11-22
K951319ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATIONRoche Diagnostic Systems, Inc.1995-06-01
K935055ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)Roche Diagnostic Systems, Inc.1994-08-09
K933572URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)Immunalysis Corporation1994-04-06
K881102MICROMEDIC MORPHINE RIA KITIcn Micromedic Systems1988-06-24
K863913THE DPC COAT-A-COUNT SERUM MORPHINE RIA KITDiagnostic Products Corp.1987-03-19
K864168MORPHINE ROCHE (R) EIA TESTRoche Diagnostic Systems, Inc.1987-03-16
K830460ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINEHoffmann-La Roche, Inc.1983-03-24
K830462ABUSCREEN RADIOUMMUNOASSAY--URINEHoffmann-La Roche, Inc.1983-03-24