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Walnut Allergen Disc

by Incstar Corp.

510(k) K874883

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 NumberK874883 Date11 May 1988ClearedStatusActive

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  • Withdrawn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, 22 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 Walnut Allergen Disc is a System, Test, Radioallergosorbent (Rast) Immunological device used in the field of Immunology. It is designed for the detection of specific IgE antibodies to walnut allergens in serum specimens.

The device is supplied as a disc and is intended for in vitro diagnostic use. It received FDA 510(k) clearance (K874883) on May 11, 1988, and is classified as a Class II medical device under regulation 866.5750. The product code is DHB, and it was found substantially equivalent to a predicate device.

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