# K191993: Yumizen C1200 CRP

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: Oct 3, 2019 after 70 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
Longest line of descent: 6 generations back to K895880 (1989). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160712: VITROS Chemistry Products hsCRP Reagent, Ortho Clinical Diagnostics (2017) Summary page 6.

## Indications for use
Yumizen C1200 CRP reagent is intended for use as a high sensitive assay for the quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay. CRP is used to evaluate conditions thought to be associated with inflammation in otherwise healthy individuals.

Source page: https://510kreport.com/device/K191993
Methodology: https://510kreport.com/methodology