Skip to content

Du Pont Tobramycin Assay Reagents

by E.I. Dupont DE Nemours & Co., Inc. 510(k)

Active United States

510(k) K850058

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK850058 Date18 Jan 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LCR
Device Class
Class II
Regulation
21 CFR Part 862.3900
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Du Pont Tobramycin Assay Reagents is a test system intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The device is supplied as a class 2 product with FDA 510(k) clearance K850058, determined to be substantially equivalent. It is manufactured by E.I. Dupont DE Nemours & Co., Inc. and is intended for use in clinical toxicology settings.

Other devices from E.I. Dupont DE Nemours & Co., Inc.

See all devices from E.I. Dupont DE Nemours & Co., Inc. →

Questions

AI-generated answers, 19 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 purpose of the Du Pont Tobramycin Assay Reagents?

    The test system measures tobramycin levels in plasma and serum, which helps in diagnosing tobramycin overdose and monitoring levels to ensure appropriate therapy.

  • How is the Du Pont Tobramycin Assay Reagents supplied?

    The device is supplied as a class 2 product manufactured by E.I. Dupont DE Nemours & Co., Inc. for use in clinical toxicology settings.

  • What is the regulatory status of the Du Pont Tobramycin Assay Reagents?

    The device has FDA 510(k) clearance K850058 and is determined to be substantially equivalent, classified under product code LCR.

  • What medical specialty is this device intended for?

    The device is intended for use in clinical toxicology settings, as indicated by its advisory committee description.