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Innofluor Amikacin Assay System

by Oxis Intl., Inc. 510(k)

Active United States

510(k) K955570

Overview

The Innofluor Amikacin Assay System is a radioimmunoassay device designed to measure the concentration of amikacin, an aminoglycoside antibiotic, in serum and plasma samples. These measurements are utilized to assist in the diagnosis and treatment of amikacin overdose and to monitor drug levels to ensure appropriate therapeutic dosing.

This device is classified as a Class 2 medical device under regulation number 862.3035. It received FDA 510(k) clearance on February 9, 1996, under the product code KLQ. The system is intended for use within clinical toxicology settings.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955570 Date9 Feb 1996ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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
KLQ
Device Class
Class II
Regulation
21 CFR Part 862.3035
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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