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Rapid One Propoxyphene Test

by American Bio Medica Corp.

510(k) K030835

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 NumberK030835 Date22 May 2003ClearedStatusActive

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  • Withdrawn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)

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, 26 Sep 2026

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

The Rapid One Propoxyphene Test is an enzyme immunoassay device designed for the detection of propoxyphene. It functions as a diagnostic tool within the field of clinical toxicology.

This device is identified by FDA 510(k) clearance number K030835 and is regulated under 21 CFR 862.3700. It is manufactured by American Bio Medica Corp.

Other devices from American Bio Medica Corp.

See all devices from American Bio Medica Corp. →

Questions

AI-generated answers, 26 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 Rapid One Propoxyphene Test used for?

    This device is an enzyme immunoassay tool designed for the detection of propoxyphene. It is utilized within the field of clinical toxicology to identify the presence of this specific substance.

  • Is this device FDA cleared?

    Yes, the Rapid One Propoxyphene Test has received FDA 510(k) clearance, identified by the number K030835. It is regulated under 21 CFR 862.3700.

  • Who is the manufacturer of this test?

    The Rapid One Propoxyphene Test is manufactured by American Bio Medica Corp., located in Columbia, Maryland.