Skip to content

Labone Cocaine Metabolite Micro-Plate Eia

by Labone, Inc.

510(k) K040198

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 NumberK040198 Date5 Mar 2004ClearedStatusActive

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  • Withdrawn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
DIO
Device Class
Class II
Regulation
21 CFR Part 862.3250
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Labone Cocaine Metabolite Micro-Plate Eia is an enzyme immunoassay for the detection of cocaine and cocaine metabolites. It is a competitive micro-plate immunoassay that uses an antibody coated on the solid surface of a micro-well to bind with cocaine metabolite in the sample.

The device is supplied as a micro-plate and is intended for use in laboratory testing procedures. It is regulated under 21 CFR 862.3250 and has been cleared by the FDA under the 510(k) number K040198. The device is used to monitor the precision and accuracy of laboratory testing procedures for cocaine metabolite.

Other devices from Labone, Inc.

Questions

AI-generated answers, 1 Oct 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 Labone Cocaine Metabolite Micro-Plate EIA used for?

    The Labone Cocaine Metabolite Micro-Plate EIA is used for the detection of cocaine and cocaine metabolites in laboratory testing procedures, helping to monitor precision and accuracy.

  • How is the device supplied?

    The device is supplied as a micro-plate, intended for use in laboratory settings.

  • Is the Labone Cocaine Metabolite Micro-Plate EIA regulated?

    Yes, the device is regulated under 21 CFR 862.3250 and has been cleared by the FDA under the 510(k) number K040198, indicating it is substantially equivalent to a predicate device.