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TDX Procainamide

by Abbott Laboratories 510(k)

Active United States

510(k) K834464

Overview

The TDX Procainamide is an Enzyme Immunoassay for Procainamide, classified under product code LAR and medical specialty Clinical Toxicology. It is a Class II medical device with Special Controls, substantially equivalent to a predicate device as determined by FDA 510(k) clearance.

The device was submitted by Abbott Laboratories from Abbott Park, Illinois, and received FDA clearance on February 3, 1984, under k-number K834464 following a traditional 510(k) review. It is regulated as an in vitro diagnostic assay for the detection of procainamide in clinical specimens.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK834464 Date3 Feb 1984ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
LAR
Device Class
Class II
Regulation
21 CFR Part 862.3320
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the TDX Procainamide used for?

    The TDX Procainamide is an enzyme immunoassay designed for the detection of procainamide in clinical specimens, used in clinical toxicology to monitor drug levels.

  • How is the TDX Procainamide supplied and is it sterile?

    The device data does not specify supply format, sterility, or single-use/reuse details for the TDX Procainamide enzyme immunoassay kit.

  • What regulatory pathway was used for the TDX Procainamide?

    The TDX Procainamide received FDA clearance through a traditional 510(k) submission (K834464) on February 3, 1984, demonstrating substantial equivalence to a predicate device under product code LAR.