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Biotrol Glucose Enzymatique Color Reagent

by Biotrol, USA, Inc.

510(k) K873117

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 NumberK873117 Date31 Aug 1987ClearedStatusActive

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  • Withdrawn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
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
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 Biotrol Glucose Enzymatique Color Reagent is a clinical chemistry device used for the quantitative determination of glucose levels. It utilizes glucose oxidase to facilitate the enzymatic reaction required for glucose measurement.

This reagent is supplied by Biotrol, USA, Inc. and has received FDA 510(k) clearance under the regulation number 862.1345. It is classified as a class 2 device within the clinical chemistry medical specialty.

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Questions

AI-generated answers, 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.

  • What is the primary use of the Biotrol Glucose Enzymatique Color Reagent?

    The Biotrol Glucose Enzymatique Color Reagent is a clinical chemistry device designed for the quantitative determination of glucose levels in a laboratory setting.

  • How does the reagent facilitate glucose measurement?

    This reagent functions by utilizing glucose oxidase to facilitate the specific enzymatic reaction required to measure glucose levels accurately.

  • What is the regulatory classification of this device?

    The device is manufactured by Biotrol, USA, Inc., and has received FDA 510(k) clearance under regulation number 862.1345. It is categorized as a class 2 device within the clinical chemistry medical specialty.