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Ultrascan IGE Assay Kit

by Specialty Medical Industries, Inc.

510(k) K872968

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 NumberK872968 Date28 Aug 1987ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 20 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 Ultrascan IGE Assay Kit is an in vitro diagnostic device used for the quantitative measurement of Immunoglobulin E (IgE) antibodies in human serum or plasma. Classified under FDA regulation 866.5510, this kit facilitates the detection and quantification of IgE levels, aiding in the diagnosis and monitoring of allergic conditions such as asthma, hay fever, and atopic dermatitis.

This kit is supplied as a single-use diagnostic reagent system and is intended for use in clinical laboratory settings. It includes components such as antigens, antiserum, and controls, all of which are designed for immunologic assays. The device received FDA 510(k) clearance under the Traditional pathway with a decision of Substantially Equivalent (SESE) in 1987, adhering to regulatory standards for diagnostic devices in immunology. Storage and handling instructions are detailed in the accompanying owner’s manual.

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