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A-Gent Theophylline

by Abbott Laboratories 510(k)

Active United States

510(k) K812003

Overview

The A-Gent Theophylline is an Enzyme Immunoassay device for Theophylline, classified as a Class II device with special controls. It is used for clinical toxicology purposes. The device is substantially equivalent and has a product code of KLS.

The A-Gent Theophylline is supplied by Abbott Laboratories and has an FDA 510K clearance with the regulation number 862.3880. The device was cleared on July 27, 1981, with a decision code of SESE. It is a traditional clearance type with a device class of 2.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK812003 Date27 Jul 1981ClearedStatusActive

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
KLS
Device Class
Class II
Regulation
21 CFR Part 862.3880
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Other devices from Abbott Laboratories

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Questions

  • What is the A-Gent Theophylline device used for?

    The A-Gent Theophylline is used for clinical toxicology purposes, specifically for the measurement of Theophylline.

  • What type of clearance does the A-Gent Theophylline have?

    The A-Gent Theophylline has an FDA 510K clearance, which indicates that it is substantially equivalent to a predicate device.

  • What is the product code for the A-Gent Theophylline?

    The product code for the A-Gent Theophylline is KLS, and it is classified as a Class II device with special controls.