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Erythrocyte Test

by Bio-Analytics Laboratories, Inc. 510(k)

Active United States

510(k) K832771

Overview

The Erythrocyte Test is a device used for red-cell count by photometry in hematology applications. It is classified as a Class II medical device under product code LKZ and regulation number 864.7100. The device is designed to measure erythrocyte levels through photometric analysis.

The Erythrocyte Test is manufactured by Bio-Analytics Laboratories, Inc. and received FDA 510(k) clearance on October 28, 1983, with K number K832771. It is intended for laboratory use and was reviewed by the Hematology advisory committee. The device is supplied as a single-use product and requires appropriate storage conditions as specified by the manufacturer.

AI-generated from registry data, 28 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 NumberK832771 Date28 Oct 1983ClearedStatusActive

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 covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LKZ
Device Class
Class II
Regulation
21 CFR Part 864.7100
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Erythrocyte Test used for?

    The Erythrocyte Test is a medical device designed for laboratory use to measure red blood cell counts through photometric analysis in hematology applications. It provides quantitative data on erythrocyte levels for diagnostic purposes.

  • How is the Erythrocyte Test supplied and is it reusable?

    The Erythrocyte Test is supplied as a single-use product, meaning it should be used for one patient procedure and then discarded. This design helps prevent cross-contamination between samples and ensures accurate results.

  • What are the storage requirements for the Erythrocyte Test?

    The Erythrocyte Test requires specific storage conditions as specified by the manufacturer, Bio-Analytics Laboratories, Inc. Proper storage is essential to maintain the device's integrity and ensure accurate test results. Users should consult the manufacturer's instructions for detailed storage guidelines.

  • What regulatory approvals does the Erythrocyte Test have?

    The Erythrocyte Test received FDA 510(k) clearance on October 28, 1983, with K number K832771. It is classified as a Class II medical device under product code LKZ and regulation number 864.7100. The device was reviewed by the Hematology advisory committee during the clearance process.