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DPC's Allergen-Specific IgE System

by Diagnostic Products Corp.

510(k) K880160

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 NumberK880160 Date21 Apr 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  • Withdrawn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, 6 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 device is a System, Test, Radioallergosorbent (Rast) Immunological, used for the detection of allergen-specific IgE in human serum. It is classified as a Class II medical device under regulation number 866.5750 and has received FDA 510(k) clearance (K880160) as substantially equivalent to a predicate device.

The system is supplied by Diagnostic Products Corp. and is intended for use in immunology laboratory settings. It is not described as sterile, single-use, reusable, or MRI-safe in the provided data, and no specific sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance are specified.

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