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Immulite Total IgE

by Diagnostic Products Corp.

510(k) K931703

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK931703 Date16 Aug 1993ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1517-2014 FDA Class II initiated 20 Dec 2013
    • Terminated Z-1518-2014 FDA Class II initiated 20 Dec 2013

    Siemens confirmed an overall average positive bias of 23% against the WHO 2nd IRP 75/502 with the IMMULITE Systems Total IgE assays.

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  • Withdrawn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, 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 Immulite Total IgE is a radioimmunoassay device for measuring total serum immunoglobulin E (IgE) levels. It falls under the category of Immunoglobulins (D, E) and is designed to quantify IgE concentrations, aiding in the evaluation of allergic and immunologic conditions.

This in vitro diagnostic device is intended for laboratory use and requires no special regulatory classification beyond its FDA 510(k) clearance (K931703) under product code JHR. Supplied as a single-use assay, it operates within the constraints of standard immunology laboratory settings and adheres to Class II – Special Controls requirements. No additional sterility or MRI safety considerations are specified.

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