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ERMA PC-602 PC-603 Blood Cell Counter

by Future Impex Corp. 510(k)

Active United States

510(k) K854678

Overview

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood. These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices.

The ERMA PC-602 PC-603 Blood Cell Counter is supplied as a Class II medical device with FDA 510(k) clearance under K854678, determined to be substantially equivalent. It is intended for use in hematology settings and is manufactured by Future Impex Corp.

AI-generated from registry data, 24 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 NumberK854678 Date24 Feb 1986ClearedStatusActive

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
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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 ERMA PC-602 PC-603 Blood Cell Counter used for?

    The ERMA PC-602 PC-603 Blood Cell Counter is used to count red blood cells, white blood cells, and blood platelets using a sample of the patient's peripheral blood. It may also measure hemoglobin or hematocrit and calculate red cell indices, making it suitable for hematology settings where automated blood analysis is required.

  • How is the ERMA PC-602 PC-603 Blood Cell Counter supplied and what is its regulatory status?

    The ERMA PC-602 PC-603 Blood Cell Counter is supplied as a Class II medical device with FDA 510(k) clearance under K854678, determined to be substantially equivalent to a predicate device. It was cleared through the traditional 510(k) pathway and is manufactured by Future Impex Corp. for use in hematology laboratories.

  • What type of blood samples does the ERMA PC-602 PC-603 Blood Cell Counter analyze?

    The ERMA PC-602 PC-603 Blood Cell Counter analyzes peripheral blood samples from patients. It is designed to count red blood cells, white blood cells, and platelets, and may additionally measure hemoglobin, hematocrit, and red cell indices as part of a complete blood count (CBC) or differential analysis in clinical hematology.