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Alatop Microplate Allergy Screen

by Diagnostic Products Corp.

510(k) K935488

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK935488 Date22 Mar 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Alatop(R) Microplate Allergy Screen
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, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Alatop Microplate Allergy Screen is a Radioallergosorbent Test (RAST) Immunological System designed for in vitro diagnostic use. It quantifies specific IgE antibodies in human serum or plasma, aiding in the diagnosis of allergic conditions by detecting sensitivities to common allergens. This microplate-based assay provides a sensitive and reproducible method for measuring allergen-specific IgE levels, supporting clinical decision-making in immunology.

This device is supplied as a single-use diagnostic kit and requires laboratory processing. It is classified under FDA regulation 21 CFR 866.5750 as a Class II device, with FDA clearance (510K K935488) granted under the Immunology advisory committee. The microplate format accommodates multiple samples simultaneously, and sterility is maintained through manufacturer-controlled packaging. Storage and handling follow standard in vitro diagnostic protocols to preserve assay integrity.

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