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Diatron Easytest Blood Glucose Moni

by Medivix, Inc.

510(k) K840484

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 NumberK840484 Date22 Jun 1984ClearedStatusActive

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  • Withdrawn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, 20 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 Diatron EasyTest Blood Glucose Monitor is a glucose oxidase-based device designed for measuring blood glucose levels. It falls under the classification of a blood glucose monitoring system, intended for point-of-care use in clinical chemistry settings. The device quantifies glucose concentrations in capillary blood samples to aid in the management of diabetes and related metabolic conditions.

This single-use, non-sterile device is supplied as a portable, handheld monitor with disposable test strips and lancets. It operates outside MRI environments and requires no special storage conditions beyond protection from extreme temperatures and moisture. The device received FDA 510(k) clearance under the product code CGA, with a traditional review pathway, and is regulated under the U.S. regulation number 862.1345. No third-party involvement is noted in its regulatory submission.

Questions

AI-generated answers, 20 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 primary use of the Diatron EasyTest Blood Glucose Monitor in clinical settings?

    The Diatron EasyTest Blood Glucose Monitor is designed for point-of-care use in clinical chemistry settings to measure glucose concentrations in capillary blood samples. It aids in the management of diabetes and related metabolic conditions by providing quantitative blood glucose readings.

  • Is the Diatron EasyTest Blood Glucose Monitor intended for single-use or reusable applications?

    The device is explicitly labeled as a single-use system. This means each test strip and lancet combination is intended for one-time use only, ensuring patient safety and accuracy.

  • What special storage conditions are required for the Diatron EasyTest Blood Glucose Monitor?

    The device does not require specialized storage conditions beyond protection from extreme temperatures and moisture. It is supplied as a portable, handheld monitor, making it suitable for general clinical environments without additional handling precautions.

  • How is the regulatory pathway for the Diatron EasyTest Blood Glucose Monitor classified in the U.S.?

    The device received FDA 510(k) clearance through a traditional review pathway, categorized under product code CGA. It is regulated under U.S. regulation number 862.1345 and was reviewed by the Clinical Chemistry (CH) advisory committee.

  • Are the test strips and lancets provided with the Diatron EasyTest Blood Glucose Monitor sterile?

    The device is described as non-sterile, meaning the test strips and lancets are not intended for sterile procedures. They are designed for single-use in non-invasive blood glucose monitoring.