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Radioimmunoassay for Total IGE Human

by Techniclone Intl.

510(k) K840103

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 NumberK840103 Date10 Feb 1984ClearedStatusActive

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  • Withdrawn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
JHR
Device Class
Class II
Regulation
21 CFR Part 866.5510
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Radioimmunoassay for Total IGE Human is a laboratory test used to measure the total amount of immunoglobulin E (IgE) in human blood samples. This device utilizes radioimmunoassay technology to quantify IgE levels, which are associated with allergic conditions and immune responses.

The device is manufactured by Techniclone Intl. and is classified as a Class II medical device with product code JHR. It is supplied as a laboratory test kit and is intended for in vitro diagnostic use. The device received FDA 510(k) clearance with number K840103 on February 10, 1984, and is regulated under 866.5510.

Questions

AI-generated answers, 1 Oct 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 Radioimmunoassay for Total IGE Human used for?

    This laboratory test is designed to measure the total amount of immunoglobulin E (IgE) in human blood samples, which helps in assessing allergic conditions and immune responses in patients.

  • How is the Radioimmunoassay for Total IGE Human supplied?

    The device is supplied as a laboratory test kit intended for in vitro diagnostic use. It contains all necessary components for performing the radioimmunoassay to quantify IgE levels in blood samples.

  • What is the regulatory status of this device?

    The Radioimmunoassay for Total IGE Human is classified as a Class II medical device with product code JHR. It received FDA 510(k) clearance with number K840103 on February 10, 1984, and is regulated under 866.5510.

  • Is this device single-use or reusable?

    The device is supplied as a laboratory test kit, which typically contains components for single-use testing. However, the specific reusability would depend on the individual components within the kit and the laboratory's protocols.