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Ames Tda Tobramycin Test

by Miles Laboratories, Inc. 510(k)

Active United States

510(k) K810941

Overview

The Ames Tda Tobramycin Test is a fluorescent immunoassay used for the detection of tobramycin. It functions as a diagnostic tool within the field of clinical toxicology.

This device is identified by FDA 510(k) number K810941 and is classified under regulation number 862.3900. It was cleared by the FDA on April 17, 1981, following a traditional submission process by Miles Laboratories, Inc.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810941 Date17 Apr 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

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

Other devices from Miles Laboratories, Inc.

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Questions

  • What is the primary purpose of the Ames Tda Tobramycin Test?

    This device is a fluorescent immunoassay designed for the detection of tobramycin. It serves as a diagnostic tool specifically intended for use within the field of clinical toxicology.

  • What is the regulatory status of this test?

    The Ames Tda Tobramycin Test was cleared by the FDA on April 17, 1981, under the 510(k) number K810941. It is classified under regulation number 862.3900 as a Class 2 device.

  • Who is the manufacturer of the Ames Tda Tobramycin Test?

    The device was submitted and manufactured by Miles Laboratories, Inc., located in McHenry, Illinois.