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Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System

by Infopia Co, Ltd.

510(k) K141750

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 · Special NumberK141750 Date24 Jul 2014ClearedStatusActive

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  • Withdrawn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, 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 Hemocue Hba1c 501 Glycosylated Hemoglobin Monitoring System is a fully automated point-of-care device designed for testing glycosylated hemoglobin. It functions as an assay system to provide diagnostic measurements of HbA1c levels.

This device is authorized under FDA 510(k) clearance. It is intended for use in clinical settings to facilitate patient monitoring.

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