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Easy Check Blood Glucose Monitoring System

by Diacare Corp.

510(k) K062538

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 NumberK062538 Date30 Apr 2007ClearedStatusActive

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  • Withdrawn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
NBW
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Easy Check Blood Glucose Monitoring System is a device used for the quantitative measurement of glucose in fresh capillary whole blood. It is designed for general chemistry applications and features individually-sealed test strips that auto-calibrate, providing results in 10 seconds. The system includes memory storage for 200 tests to track and compare results over time.

This device is supplied as a monitoring system with test strips and is intended for single-use applications. It is MRI safe and requires proper storage conditions as specified by the manufacturer. The Easy Check Blood Glucose Monitoring System has received FDA 510(k) clearance with the product code NBW and is authorized for use in clinical settings.

Questions

AI-generated answers, 22 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 Easy Check Blood Glucose Monitoring System used for?

    The Easy Check Blood Glucose Monitoring System is designed for the quantitative measurement of glucose in fresh capillary whole blood, intended for general chemistry applications in clinical settings.

  • How is the Easy Check Blood Glucose Monitoring System supplied?

    The system is supplied as a complete monitoring system with test strips included. The test strips are individually sealed and designed for single-use applications only.

  • What are the key features of the Easy Check Blood Glucose Monitoring System?

    The system features auto-calibrating test strips that provide results in 10 seconds, memory storage for 200 tests to track and compare results over time, and is MRI safe for patient safety.

  • What is the regulatory status of the Easy Check Blood Glucose Monitoring System?

    The Easy Check Blood Glucose Monitoring System has received FDA 510(k) clearance with the product code NBW and is authorized for use in clinical settings, with clearance granted on April 30, 2007.