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Retic Control-M Hematology Control/Multiple

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

510(k) K943335 Product code JPK

Overview

The Retic Control-M Hematology Control/Multiple is a hematology quality control mixture used for calibrating and verifying the performance of hematology analyzers. This control material is designed to provide consistent and reliable results for reticulocyte testing in clinical laboratories.

The device is supplied as a multiple parameter hematology control and is intended for single-use in laboratory settings. It is stored according to manufacturer guidelines and has received FDA 510(k) clearance with the product code JPK. The device is classified as Class II and is regulated under 864.8625.

Summary written by AI from registry data, 6 Oct 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 NumberK943335 Date12 Dec 1994ClearedStatusActive

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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  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
JPK
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Retic Control-M Hematology Control/Multiple used for?

    The Retic Control-M is a hematology quality control mixture designed for calibrating and verifying the performance of hematology analyzers, specifically for reticulocyte testing in clinical laboratories.

  • How is the Retic Control-M supplied and is it single-use or reusable?

    The device is supplied as a multiple parameter hematology control and is intended for single-use in laboratory settings. It should be used according to manufacturer guidelines for optimal results.

  • What is the regulatory status of the Retic Control-M Hematology Control/Multiple?

    The device has received FDA 510(k) clearance with the product code JPK. It is classified as Class II and is regulated under 864.8625.

  • How should the Retic Control-M be stored?

    The device should be stored according to manufacturer guidelines to maintain its integrity and ensure reliable performance in laboratory testing.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K943335 24 fields · synced 22 Oct 2026