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Rapidone-Ecstasy Test

by American Bio Medica Corp.

510(k) K013180

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 NumberK013180 Date26 Nov 2001ClearedStatusActive

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  • Withdrawn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
DJC
Device class
Class II
Regulation
21 CFR Part 862.3610
Advisory committee
Clinical Toxicology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

This device is a Thin Layer Chromatography test for Methamphetamine, classified under Clinical Toxicology. It is designed to detect methamphetamine in biological samples using thin layer chromatography methodology.

It is supplied as a diagnostic test kit for use in clinical laboratory settings. The device received FDA 510(k) clearance (K013180) on November 26, 2001, and is classified as a Class II medical device under regulation number 862.3610 with product code DJC.

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Questions

AI-generated answers, 23 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 RAPIDONE-ECSTASY TEST used for?

    The RAPIDONE-ECSTASY TEST is designed to detect methamphetamine in biological samples using thin layer chromatography methodology, as specified in its description for clinical toxicology applications.

  • How is the RAPIDONE-ECSTASY TEST supplied and where is it intended for use?

    It is supplied as a diagnostic test kit for use in clinical laboratory settings, intended for professional testing of biological samples to identify methamphetamine presence.

  • What regulatory clearance does the RAPIDONE-ECSTASY TEST have and when was it granted?

    The device received FDA 510(k) clearance (K013180) on November 26, 2001, and is classified as a Class II medical device under regulation number 862.3610 with product code DJC.