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Kit, RIA, Gentamicin Sulf.

by New England Nuclear

510(k) K760068

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760068 Date20 Jul 1976ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DJB
Device Class
Class II
Regulation
21 CFR Part 862.3450
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a radioimmunoassay kit for gentamicin (125-I) with second antibody separation, classified under product code DJB and regulation number 862.3450. It is intended for use in clinical toxicology to measure gentamicin levels in biological specimens.

The kit was cleared by the FDA through the 510(k) process under number K760068 on July 20, 1976, and is manufactured by New England Nuclear. It is a Class II medical device subject to special controls, with no indication of sterility, single-use status, MRI safety, sizes, or storage conditions provided in the data.

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Questions

AI-generated answers, 24 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 KIT, RIA, GENTAMICIN SULF. used for?

    This device is a radioimmunoassay kit designed to measure gentamicin levels in biological specimens using 125-I labeled gentamicin and second antibody separation, intended for use in clinical toxicology to monitor antibiotic concentrations.

  • How is the KIT, RIA, GENTAMICIN SULF. supplied and what are its components?

    The kit is supplied as a radioimmunoassay system containing 125-I labeled gentamicin and reagents for second antibody separation, though specific component details, sizes, or packaging configurations are not provided in the device data.

  • Is the KIT, RIA, GENTAMICIN SULF. sterile or single-use?

    The device data does not specify whether the kit is sterile, single-use, or reusable; no information on sterility status or disposal instructions is included in the provided specifications.