# K082162: Coulter Body Fluid Control

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 3, 2009 after 187 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: 2 generations back to K912133 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912133: PX Coulter (R) Cell Control, Coulter Electronics, Inc. (1991) Summary page 1.
- K060464: Coulter 5C Cell Control, Beckman Coulter, Inc. (2006) Summary page 1.

## Indications for use
Body Fluid Control is a hematology quality control material used to monitor the performance and verify the measuring range of the body fluid cycle of the UniCel® DxH 800 COULTER Cellular Analysis System. Refer to the System HELP or Instructions for Use. The assigned values and expected ranges on the TABLE OF EXPECTED RESULTS can be used to monitor performance, and verify the measurable range. This product can also be used to establish your own laboratory mean.

Source page: https://510kreport.com/device/K082162
Methodology: https://510kreport.com/methodology