Skip to content

HGB3 (1:251)

by R&D Systems, Inc. United States 510(k)

510(k) K802266 Product code GKR

Overview

The HGB3 (1:251) is a System, Hemoglobin, Automated, as defined by its device type and nomenclature. It is an in vitro diagnostic device used for the automated measurement of hemoglobin levels in blood samples.

This device was cleared through the FDA 510(k) process under K802266 with a decision date of October 23, 1980, and is classified as a Class II device with product code GKR. It is intended for use in hematology testing and is supplied as a non-sterile, reusable system for laboratory environments.

Summary written by AI from registry data, 26 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802266 Date23 Oct 1980ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

510(k) Number
FDA Product Code
GKR
Device Class
Class II
Regulation
21 CFR Part 864.5620
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Other devices from R&D Systems, Inc.

See all devices from R&D Systems, Inc. →

Questions

  • What is the HGB3 (1:251) used for?

    The HGB3 (1:251) is an in vitro diagnostic device used for the automated measurement of hemoglobin levels in blood samples, intended for hematology testing in laboratory environments.

  • How is the HGB3 (1:251) supplied and is it sterile or reusable?

    The HGB3 (1:251) is supplied as a non-sterile, reusable system designed for use in laboratory settings, meaning it can be cleaned and reused according to manufacturer instructions.

  • What regulatory pathway was used for the HGB3 (1:251) and what is its classification?

    The HGB3 (1:251) was cleared through the FDA 510(k) process under K802266 and is classified as a Class II device with product code GKR.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K802266 24 fields · synced 6 Oct 2026