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Cat Epithelium Allergen Disc

by Incstar Corp.

510(k) K870264

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 NumberK870264 Date13 Feb 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  • Withdrawn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
DHB
Device Class
Class II
Regulation
21 CFR Part 866.5750
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 Cat Epithelium Allergen Disc is a diagnostic device classified as a System, Test, Radioallergosorbent (RAST) Immunological. It is designed for in vitro allergen testing to detect specific immunoglobulin E (IgE) antibodies in human serum, aiding in the diagnosis of allergic reactions to cat epithelium allergens.

This device is supplied as a single-use disc and is intended for use in clinical immunology laboratories. It requires FDA 510(k) clearance (K870264) and falls under product code DHB, regulated under 21 CFR 866.5750. Sterility and handling instructions are not specified in the data, but it is classified as a Class II medical device. Storage conditions and additional regulatory details are not provided in the available records.

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