# K061064: Coulter Lin-C Linearity Control, Models 7547065, 723503

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 17, 2006 after 30 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 K955334 (1996). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955334: Coulter Linearity Control, Coulter Corp. (1996) Summary page 1.

## Most influential descendants
- K081641: Coulter Lin-X Linearity Control (2009), 1 descendant of its own
- K100790: Coulter Lin-X Linearity Control, Model A81196 (2010), 0 descendants of its own

## Indications for use
COULTER LIN-C linearity controls are intended to verify the reportable range of COULTER hematology analyzers listed in the TABLE OF EXPECTED RESULTS in conjunction with specific COULTER reagents. Refer to your Product Manuals or On-line Help System.

Source page: https://510kreport.com/device/K061064
Methodology: https://510kreport.com/methodology