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Leukocyte Vol. Analysis Apparatus

by Coulter Electronics, Inc. 510(k)

Active United States

510(k) K802208

Overview

The Leukocyte Volume Analysis Apparatus is a counter, cell, automated (particle counter) device used in hematology. It is designed to analyze leukocyte volume as an automated particle counter.

This device received FDA 510(k) clearance (K802208) on September 17, 1980, and is classified as a Class II medical device under regulation 864.5200. It was submitted by Coulter Electronics, Inc. and determined to be substantially equivalent.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802208 Date17 Sep 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
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  • 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 is the Leukocyte Volume Analysis Apparatus used for?

    The Leukocyte Volume Analysis Apparatus is used in hematology as an automated particle counter to analyze leukocyte volume. It counts and sizes cells to provide volumetric data for white blood cells, supporting diagnostic evaluations in clinical laboratories.

  • How is the Leukocyte Volume Analysis Apparatus supplied and is it reusable?

    The device is supplied as a benchtop automated analyzer intended for repeated use in laboratory settings. It is not a single-use device; rather, it is a reusable instrument requiring regular maintenance, calibration, and quality control to ensure accurate leukocyte volume measurements over time.

  • What regulatory pathway was used for the Leukocyte Volume Analysis Apparatus?

    The Leukocyte Volume Analysis Apparatus received FDA 510(k) clearance under submission K802208, demonstrating substantial equivalence to a legally marketed predicate device. This traditional 510(k) pathway was used for its Class II classification under regulation 864.5200.