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Accu-Chek A1C Hemoglobin Test

by Boehringer Mannheim Corp.

510(k) K974491

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 NumberK974491 Date13 May 1998ClearedStatusActive

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  • Withdrawn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
LCP
Device Class
Class II
Regulation
21 CFR Part 864.7470
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Accu-Chek A1c Hemoglobin Test is an assay for glycosylated hemoglobin used for the collection of whole blood samples. It functions as a diagnostic tool to facilitate the testing of hemoglobin A1c levels.

This device is intended for use by patients or clinicians in home or office settings. The system includes test strips, disposable lancets, a patient ID card, and a return envelope for mailing the collected sample to a laboratory for analysis. It has received FDA 510(k) clearance.

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Questions

AI-generated answers, 25 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 Accu-Chek A1c Hemoglobin Test?

    This device is a diagnostic tool designed to facilitate the testing of hemoglobin A1c levels by collecting whole blood samples for laboratory analysis.

  • Who can use this hemoglobin test system?

    The system is intended for use by both patients and clinicians, allowing for sample collection in either home or office settings.

  • What components are included in the test kit?

    The system is supplied with test strips, disposable lancets for blood collection, a patient ID card, and a return envelope to mail the sample to a laboratory.

  • Is this device cleared for use?

    Yes, the Accu-Chek A1c Hemoglobin Test has received FDA 510(k) clearance as a diagnostic assay for glycosylated hemoglobin.