# K091303: Liquichek Hematology-16 Control LV, Model: 295LV

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Aug 2, 2010 after 455 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 K902389 (1990). 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)
- K902389: Tri-Count 16, Hematronix, Inc. (1990) Summary page 1.

## Indications for use
Liquichek Hematology-16 Control LV Is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), WBC (White Blood Cells).

Source page: https://510kreport.com/device/K091303
Methodology: https://510kreport.com/methodology