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Synchron Systems Enzyme Validator Set Levels 1 and 2

by Beckman Coulter, Inc.

510(k) K032287

Active European Union and United States

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K032287↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK032287 Date18 Aug 2003ClearedStatusActive
European UnionCE/IVDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K032287 decided 18 Aug 2003 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Modification to Synchron Systems Enzyme Validator Set Levels 1 and 2
510(k) Number
FDA product code
JIX
Device class
Class II
Regulation
21 CFR Part 862.1150
Advisory committee
Clinical Chemistry
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

This device is a Calibrator, Multi-Analyte Mixture designed to provide reference points for calibrating enzyme assays on Beckman SYNCHRON Systems. It functions as a quality control tool to ensure accurate measurement of selected human enzymes in clinical chemistry applications.

The Enzyme Validator Set consists of two liquid calibrator levels (3 x 5 mL bottles each), supplied as a single-use, non-sterile reagent. It is intended for use in clinical laboratories and is regulated under FDA 510K and IVDD authorizations. The device is classified as Class II and adheres to regulatory requirements outlined in 862.1150.

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