# K003342: Wako CRP-UL, CRP-UL Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Jan 22, 2001 after 89 days
- Product code: DCN (System, Test, C-Reactive Protein)
- 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; 2 cite 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
- K021882: Crpex-HS CRP Calibrator Set, Catalog NO: 1510 (2002), 0 descendants of its own
- K020603: Crpex-HS C-Reactive Protein Lit Assay, Catalog NO. 1010 (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K003342
Methodology: https://510kreport.com/methodology