# K003372: Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRP

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Dec 26, 2000 after 57 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K071017: Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP (600 Tests) (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K003372
Methodology: https://510kreport.com/methodology