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AG-695 Single and Multi Blood Glucose Monitoring System/AG-696 Single and Multi Blood Glucose Monitoring System

by Andon Medical Co., Ltd.

510(k) K093755

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 NumberK093755 Date15 Jul 2011ClearedStatusActive

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  • Withdrawn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, 19 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-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM is a blood glucose monitoring system intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples from the fingertip. It is designed for use by a single person and should not be shared.

The device is supplied as a monitoring system and is authorized under FDA 510(k) clearance (K093755) with product code NBW. It is intended for use in clinical chemistry settings as indicated by the advisory committee classification.

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Questions

AI-generated answers, 19 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 AG-695/AG-696 Blood Glucose Monitoring System intended to measure?

    The AG-695 and AG-696 systems are intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples obtained from the fingertip. This measurement is performed to monitor blood glucose levels in individuals managing diabetes or related conditions.

  • Who is the AG-695/AG-696 Blood Glucose Monitoring System designed for, and can it be shared between users?

    The device is designed for use by a single person and should not be shared between individuals. This restriction is in place to prevent cross-contamination and ensure accurate, safe operation for each user, as sharing could compromise test results and pose infection risks.

  • What regulatory pathway was used to authorize the AG-695/AG-696 Blood Glucose Monitoring System, and what is its 510(k) number?

    The AG-695 and AG-696 systems were authorized under the FDA 510(k) clearance pathway, specifically under submission K093755. This indicates the device was found substantially equivalent to a legally marketed predicate device, allowing it to be legally distributed in the United States.

  • What product code and advisory committee classification apply to the AG-695/AG-696 Blood Glucose Monitoring System?

    The device is assigned product code NBW and was reviewed by the Clinical Chemistry advisory committee (CH). This classification reflects its intended use in measuring glucose in blood samples within clinical chemistry settings, based on the regulatory filing pathway, not a direct clinical indication.