# K081641: Coulter Lin-X Linearity Control

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 16, 2009 after 219 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 K955334 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K061064: Coulter Lin-C Linearity Control, Models 7547065, 723503, Beckman Coulter, Inc. (2006) Summary page 1.
- K942822: CBC-Line Hematology Linearity Control, R&D Systems, Inc. (1994) Summary page 1.

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

## Indications for use
COULTER LIN-X linearity controls are intended to assess calibration and verify the reportable range of COULTER cellular analysis systems 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/K081641
Methodology: https://510kreport.com/methodology