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PARA-7 Hematology Quality Control Mixture

by Streck Laboratories, Inc.

510(k) K791227

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K791227↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK791227 Date3 Aug 1979ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Para-7
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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Para-7 is a Mixture, Hematology Quality Control, designed for use in hematology laboratories to monitor and validate the performance of automated hematology analyzers. It serves as a standardized control material to ensure accuracy, precision, and reliability of blood cell counting and differential analysis, helping maintain compliance with laboratory quality standards.

This product is supplied as a liquid control reagent, intended for single-use in clinical settings. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and IVDR conformity. The Para-7 is distributed in pre-filled containers and must be stored under refrigeration (2–8°C) to preserve stability. No MRI safety considerations are specified, and its use is governed by the regulatory requirements outlined in 21 CFR 864.8625.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Para-7 used for in a hematology lab, and how does it help ensure accuracy in testing?

    The Para-7 is a liquid hematology quality control mixture designed to monitor and validate automated blood cell counters. It provides standardized reference values for red blood cells, white blood cells, platelets, and differential counts, helping labs verify the precision and accuracy of their analyzers. Regular use ensures compliance with quality standards and maintains reliable test results.

  • Is the Para-7 intended for single-use or repeated use, and how should it be stored?

    The Para-7 is supplied as a single-use liquid control reagent in pre-filled containers. To maintain stability, it must be stored under refrigeration between 2–8°C. Do not reuse—each container is meant for one testing session only.

  • What regulatory pathways has the Para-7 followed, and which governing body oversees its compliance?

    The Para-7 has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device. It also complies with the In Vitro Diagnostic Regulation (IVDR). The device is governed by 21 CFR 864.8625, ensuring its use aligns with hematology quality control standards.

  • Are there different sizes or models of the Para-7, and how would I identify the correct one for my lab?

    The Para-7 is supplied in pre-filled containers, but no distinct size or model variations are explicitly listed in the data. The product is standardized for general hematology analyzer validation. Verify compatibility with your analyzer’s manufacturer guidelines, as some systems may require specific control types.