# K010597: Synchron LX Systems High Sensitivity C-Reactive Protien (CRPH) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: May 29, 2001 after 90 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070626: Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent (2007), 1 descendant of its own
- K091052: Piccolo C-Reactive Protein (CRP) Test System (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K010597
Methodology: https://510kreport.com/methodology