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HA/5 Hematology Analyzer

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K760581

Overview

The HA/5 Hematology Analyzer is an automated cell counter designed for hematological analysis. It performs automated differential and complete blood counts, including measurements of red blood cells, white blood cells, hemoglobin, hematocrit, and platelet counts. This device is classified as a Class II medical device under FDA regulations and falls under the category of automated particle counters for hematology.

The HA/5 Hematology Analyzer is intended for use in clinical laboratories and healthcare settings. It is a reusable device, supplied sterile or non-sterile depending on the specific configuration and usage requirements. The analyzer operates within standard laboratory environments and is not MRI-compatible. It is authorized for use in the United States under FDA 510(k) clearance (K760581) and adheres to regulatory standards outlined in 21 CFR 864.5200. No additional sterility or single-use specifications are provided beyond standard laboratory practices.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760581 Date9 Nov 1976ClearedStatusActive

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
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  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GKL
Device Class
Class II
Regulation
21 CFR Part 864.5200
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What clinical measurements does the HA/5 Hematology Analyzer perform?

    The HA/5 Hematology Analyzer automates comprehensive hematological analysis, including red blood cell (RBC) counts, white blood cell (WBC) counts, hemoglobin levels, hematocrit percentages, and platelet counts. It also provides automated differential counts, enabling detailed evaluation of blood cell morphology and proportions.

  • Is the HA/5 Hematology Analyzer reusable or single-use?

    The HA/5 Hematology Analyzer is designed as a reusable device. It is supplied either sterile or non-sterile based on the configuration and intended use, adhering to standard laboratory practices for maintenance and reprocessing.

  • What regulatory pathway does the HA/5 Hematology Analyzer follow?

    The HA/5 Hematology Analyzer is authorized for use in the United States under FDA 510(k) clearance (K760581). It was classified as substantially equivalent to a predicate device and falls under the regulatory category of automated particle counters for hematology, governed by 21 CFR 864.5200.

  • Can the HA/5 Hematology Analyzer be used in MRI environments?

    No, the HA/5 Hematology Analyzer is not MRI-compatible. It is intended for use in standard clinical laboratory environments where MRI compatibility is not required.

  • What types of settings is the HA/5 Hematology Analyzer intended for?

    The HA/5 Hematology Analyzer is specifically designed for clinical laboratories and healthcare settings where precise hematological analysis is required. Its automated capabilities make it suitable for high-volume environments where efficiency and accuracy in blood testing are critical.