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Abuscreen Online Propoxyphene

by Roche Diagnostic Systems, Inc.

510(k) K945195

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945195 Date9 Dec 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Abuscreen Online Propoxphene
510(k) Number
FDA Product Code
JXN
Device Class
Class II
Regulation
21 CFR Part 862.3700
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An enzyme immunoassay for propoxyphene, classified under Clinical Toxicology. This in vitro diagnostic device is designed to detect propoxyphene in specimens using immunoassay methodology.

Supplied for use in laboratory settings, the device is a traditional 510(k) cleared product with product code JXN and regulation number 862.3700. It was cleared by the FDA on December 9, 1994, under K945195, and is intended for use as substantially equivalent to a legally marketed device.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ABUSCREEN ONLINE PROPOXPHENE device used for?

    The ABUSCREEN ONLINE PROPOXPHENE is an enzyme immunoassay designed to detect propoxyphene in specimens using immunoassay methodology, intended for use in clinical toxicology laboratory settings to support drug screening processes.

  • How is the ABUSCREEN ONLINE PROPOXPHENE supplied and for what setting is it intended?

    The device is supplied for use in laboratory settings as a traditional in vitro diagnostic test, designed to be operated by trained personnel in clinical laboratories to analyze specimens for the presence of propoxyphene.

  • What regulatory pathway was used for the ABUSCREEN ONLINE PROPOXPHENE and when was it cleared?

    The ABUSCREEN ONLINE PROPOXPHENE was cleared through the FDA's traditional 510(k) pathway under submission K945195, with a clearance date of December 9, 1994, based on a determination of substantial equivalence to a legally marketed device.