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Synchron Systems Enzymatic CO2 (CO2E) Reagent, Model A60291

by Beckman Coulter, Inc.

510(k) K091153

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091153 Date13 Jul 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
KHS
Device Class
Class II
Regulation
21 CFR Part 862.1160
Advisory Committee
Clinical Chemistry
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.

This device is an in vitro diagnostic assay for the quantitative determination of carbon dioxide in human serum or plasma. It is designed for use with the UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1 and 3.

The reagent is supplied for use by laboratory personnel in clinical chemistry settings. It has received FDA 510(k) clearance under product code KHS and regulation number 862.1160, with the decision date of July 13, 2009, and is classified as a Class II device.

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Questions

AI-generated answers, 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.

  • What is the SYNCHRON SYSTEMS ENZYMATIC CO2 REAGENT, MODEL A60291 used for?

    This reagent is an in vitro diagnostic assay designed for the quantitative determination of carbon dioxide in human serum or plasma, enabling clinical laboratories to measure CO2 levels as part of routine blood chemistry analysis.

  • Which systems is the SYNCHRON SYSTEMS ENZYMATIC CO2 REAGENT, MODEL A60291 compatible with?

    It is designed for use with the UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1 and 3, ensuring proper integration and performance within Beckman Coulter's clinical chemistry platforms.

  • How is the SYNCHRON SYSTEMS ENZYMATIC CO2 REAGENT, MODEL A60291 supplied and intended for use?

    The reagent is supplied for use by laboratory personnel in clinical chemistry settings, meaning it is intended for professional handling in controlled laboratory environments to perform carbon dioxide testing on patient specimens.