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Glucolab Blood Glucose Monitoring System

by Infopia Co, Ltd.

510(k) K051285

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 NumberK051285 Date2 Aug 2005ClearedStatusActive

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  • Withdrawn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, 23 Sep 2026

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

The Glucolab Blood Glucose Monitoring System is a device used for measuring glucose levels in blood. It operates based on glucose oxidase technology to provide accurate blood glucose readings.

This system is intended for single-use and is regulated under FDA 510K clearance with product code CGA. It is supplied in various sizes and should be stored according to manufacturer instructions. The device is classified under Clinical Chemistry medical specialty.

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Questions

AI-generated answers, 23 Sep 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 Glucolab Blood Glucose Monitoring System used for?

    The Glucolab Blood Glucose Monitoring System is designed for measuring glucose levels in blood, providing accurate readings through glucose oxidase technology.

  • Is the Glucolab Blood Glucose Monitoring System single-use or reusable?

    The Glucolab Blood Glucose Monitoring System is intended for single-use only, ensuring hygiene and accuracy for each test.

  • What sizes and models are available for the Glucolab Blood Glucose Monitoring System?

    The Glucolab Blood Glucose Monitoring System is supplied in various sizes to accommodate different testing needs, though specific model details should be confirmed with the manufacturer.

  • How should the Glucolab Blood Glucose Monitoring System be stored?

    The Glucolab Blood Glucose Monitoring System should be stored according to the manufacturer's instructions to maintain its functionality and accuracy.

  • What is the regulatory classification of the Glucolab Blood Glucose Monitoring System?

    The Glucolab Blood Glucose Monitoring System is regulated under FDA 510K clearance with product code CGA and classified under Clinical Chemistry medical specialty.