# K041457: Liquichek Hematology Control (a)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 28, 2004 after 27 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960471 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960471: Tri-Count 20, Hematronix, Inc. (1996) Summary page 1.

## Indications for use
Liquichek Hematology Control (A) Is an assayed whole blood control for evaluating precision of hematology Instruments that provide a white blood cell differential.

Source page: https://510kreport.com/device/K041457
Methodology: https://510kreport.com/methodology