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Immunoglobulin G (IgG)

by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

510(k) K221114

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 NumberK221114 Date2 Aug 2023ClearedStatusActive

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  • Withdrawn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
CFN
Device Class
Class II
Regulation
21 CFR Part 866.5510
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.

Immunoglobulin G (IgG) is a nephelometric in‑vitro diagnostic reagent used for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid. The method measures light scattering to provide a numerical concentration of IgG, supporting assessment of protein metabolism and immune status.

The reagent is supplied as a system kit for use on Beckman Coulter AU/DxC AU analyzers. It is classified as a Class 2 immunology device (product code CFN) and has been cleared through the traditional FDA 510(k) pathway (K221114, decision date 2023‑08‑02). The kit is intended for single‑use, in‑vitro diagnostic testing in clinical laboratories.

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