FDA.reportPublic FDA data

510(k) K010967

Device
LIVESURE COCAINE SCREEN TEST
Applicant
Pan Probe Biotech, Inc.
510(k) number
K010967
Product code
DIO
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-17
Date received
2001-04-02
Regulation
862.3250
Classification name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
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

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