JPK · Class II · 21 CFR 864.8625

FDA Product Code JPK: Mixture, Hematology Quality Control

Accurate hematology analyzers require regular performance verification. FDA product code JPK covers hematology quality control mixtures used to verify analyzer performance.

These stabilized blood cell-based or synthetic materials are run on hematology analyzers to confirm that instrument results for cell counts and indices fall within established acceptable ranges, ensuring the reliability of patient results reported by the laboratory.

JPK devices are Class II medical devices, regulated under 21 CFR 864.8625 and reviewed by the FDA Hematology panel.

Leading manufacturers include Streck and R&D Systems, Inc..

4
Total
4
Cleared
268d
Avg days
2016
Since

List of Mixture, Hematology Quality Control devices cleared through 510(k)

4 devices
1–4 of 4
Cleared Dec 22, 2016
XN-L CHECK
K160586
Streck
Hematology · 296d
Cleared Dec 22, 2016
XN CHECK BF
K160588
Streck
Hematology · 296d
Cleared Dec 22, 2016
XN CHECK
K160590
Streck
Hematology · 296d
Cleared Sep 01, 2016
BC-5D Hematology Control
K160606
R&D Systems, Inc.
Hematology · 183d

How to use this database

This page lists all FDA 510(k) submissions for Mixture, Hematology Quality Control devices (product code JPK). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Hematology FDA review panel. Browse all Hematology devices →