510(k) K013100

Device
PROPOXYPHENE
Applicant
Abbott Laboratories
510(k) number
K013100
Product code
JXN
Decision
Substantially Equivalent (SESE)
Decision date
2002-03-20
Date received
2001-09-17
Regulation
862.3700
Classification name
Enzyme Immunoassay, Propoxyphene
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
LINDA MORRIS
Address
1920 Hurd Dr. Irving TX US 75038 75038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)Lin-Zhi International, Inc.2003-01-21
K022915INSTANT-VIEW PROPOXYPHENE (PPX) URINE TESTAlfa Scientific Designs, Inc.2002-11-29
K020787VERDICT-II PROPOXYPHENEMedtox Diagnostics, Inc.2002-05-02
K011163MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229Syva Co., Dade Behring, Inc.2001-05-10
K993981SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129ULSyva Co.2000-02-01
K983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENERoche Diagnostic Systems, Inc.1998-12-11
K955675SYNCHRON SYSTEMS PROPOXYPHENE REAGENTBeckman Instruments, Inc.1996-02-09
K951133CEDIA DAU PROPOXYPHENE ASSAYMicrogenics Corp.1995-05-02
K944372STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIASolarcare, Inc.1995-02-08