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Flipscreen Qat

by Alerchek, Inc.

510(k) K874802

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 NumberK874802 Date17 Feb 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  • Withdrawn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 FLIPSCREEN QAT is a System, Test, Radioallergosorbent (Rast) Immunological device used for allergy testing in the field of immunology. It is designed to detect specific IgE antibodies in patient serum to identify allergic sensitivities.

The device is supplied as a single-use test system and is not indicated for MRI compatibility. It is stored according to manufacturer instructions and has received FDA 510(k) clearance with product code DHB. The device is classified as Class II and is intended for use in immunology testing settings.

Other devices from Alerchek, Inc.

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 FLIPSCREEN QAT used for?

    The FLIPSCREEN QAT is a System, Test, Radioallergosorbent (Rast) Immunological device designed to detect specific IgE antibodies in patient serum to identify allergic sensitivities in immunology testing settings.

  • Is the FLIPSCREEN QAT a single-use device?

    Yes, the FLIPSCREEN QAT is supplied as a single-use test system and is not intended for reuse. It should be discarded after a single use according to the manufacturer's instructions.

  • What is the regulatory status of the FLIPSCREEN QAT?

    The FLIPSCREEN QAT has received FDA 510(k) clearance with product code DHB and is classified as Class II. It is intended for use in immunology testing settings and is not indicated for MRI compatibility.

  • How should the FLIPSCREEN QAT be stored?

    The FLIPSCREEN QAT should be stored according to the manufacturer's instructions. Specific storage conditions are not detailed in the provided information, so users should refer to the product documentation for proper storage requirements.