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AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring System

by Andon Medical Co., Ltd.

510(k) K093262

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 NumberK093262 Date13 Jul 2010ClearedStatusActive

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  • Withdrawn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 AG-608 and AG-610 Blood Glucose Monitoring Systems are devices for the quantitative measurement of glucose in fresh capillary blood samples. These systems consist of a meter, test strips, lancets, lancing device, and optional control solutions, utilizing electrochemical biosensor technology where capillary action draws blood into the test strip chamber.

The systems are supplied as complete monitoring kits and are intended for single-use applications. They are MRI safety compliant and have received FDA 510(k) clearance with K number K093262, classified under product code NBW. The devices are stored according to manufacturer specifications and are authorized for use in clinical settings.

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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 purpose of the AG-608 and AG-610 Blood Glucose Monitoring Systems?

    These devices are designed for the quantitative measurement of glucose in fresh capillary blood samples. They utilize electrochemical biosensor technology where capillary action draws blood into the test strip chamber for accurate readings.

  • What components are included in the AG-608 and AG-610 monitoring systems?

    The systems are supplied as complete monitoring kits that include a meter, test strips, lancets, lancing device, and optional control solutions. All components work together to provide comprehensive blood glucose monitoring capabilities.

  • Are the AG-608 and AG-610 Blood Glucose Monitoring Systems single-use or reusable?

    These systems are intended for single-use applications. While the meter itself may be reused, the test strips, lancets, and lancing device are designed for single patient use to ensure hygiene and accurate results.

  • What regulatory approvals have the AG-608 and AG-610 systems received?

    Both systems have received FDA 510(k) clearance with K number K093262 and are classified under product code NBW. They are MRI safety compliant and authorized for use in clinical settings, meeting regulatory requirements for blood glucose monitoring devices.