JXN · Class II · 21 CFR 862.3700

FDA Product Code JXN: Enzyme Immunoassay, Propoxyphene

Leading manufacturers include Syva Co., Abbott Laboratories and Roche Diagnostic Systems, Inc..

22
Total
22
Cleared
82d
Avg days
1985
Since

FDA 510(k) Cleared Enzyme Immunoassay, Propoxyphene Devices (Product Code JXN)

22 devices
1–22 of 22
Cleared Nov 23, 2015
Wondfo Propoxyphene Urine Test
K152495
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 83d
Cleared Mar 11, 2005
ONLINE DAT PROPOXYPHENE PLUS
K043303
Roche Diagnostics Corp.
Toxicology · 101d
Cleared Mar 20, 2002
PROPOXYPHENE
K013100
Abbott Laboratories
Toxicology · 184d
Cleared Feb 01, 2000
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
K993981
Syva Co.
Toxicology · 69d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
K983700
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Feb 09, 1996
SYNCHRON SYSTEMS PROPOXYPHENE REAGENT
K955675
Beckman Instruments, Inc.
Toxicology · 56d
Cleared Dec 09, 1994
ABUSCREEN ONLINE PROPOXPHENE
K945195
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Nov 02, 1992
SYVA EMIT II PROPOXYPHENE ASSAY
K923873
Syva Co.
Toxicology · 91d
Cleared Aug 16, 1991
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS
K912365
Abbott Laboratories
Toxicology · 79d
Cleared Oct 28, 1987
REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS
K874200
Syva Co.
Toxicology · 14d
Cleared Apr 02, 1985
EMIT D.A.U. PROPOXYPHENE ASSAY
K850920
Syva Co.
Toxicology · 28d

About Product Code JXN - Regulatory Context