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Sweet Vernal Allergen Disc

by Incstar Corp.

510(k) K871723

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 NumberK871723 Date13 Jul 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  • Withdrawn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, 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 Sweet Vernal Allergen Disc is a Class 2 immunological device used for allergy testing. It is part of a Radioallergosorbent (Rast) Immunological Test System designed to detect allergic reactions to sweet vernal grass allergens.

This device is supplied as a single-use disc and is regulated under product code DHB with FDA 510(k) clearance K871723. It is intended for use in immunology settings and requires appropriate storage conditions as specified by the manufacturer.

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Questions

AI-generated answers, 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.

  • What is the Sweet Vernal Allergen Disc used for?

    The Sweet Vernal Allergen Disc is a Class 2 immunological device used for allergy testing. It is part of a Radioallergosorbent (Rast) Immunological Test System designed to detect allergic reactions specifically to sweet vernal grass allergens.

  • How is the Sweet Vernal Allergen Disc supplied?

    The device is supplied as a single-use disc and is regulated under product code DHB. It is intended for use in immunology settings and requires appropriate storage conditions as specified by the manufacturer.

  • What is the regulatory status of the Sweet Vernal Allergen Disc?

    The Sweet Vernal Allergen Disc has FDA 510(k) clearance K871723 and is classified as a Class 2 device. It was determined to be substantially equivalent through a traditional review process by the Immunology advisory committee.

  • Can the Sweet Vernal Allergen Disc be reused?

    No, the Sweet Vernal Allergen Disc is supplied as a single-use device and should not be reused. Each disc is designed for one-time use only to ensure accurate test results and maintain sterility.