# K944288: Hemagen C-Reactive Protein Kit (Eia Method)

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Oct 3, 1994 after 31 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K984132: Immulite C-Reactive Protein, Models LKC1, LKC5 (1999), 1 descendant of its own
- K990886: Immulite C-Reactive Protein, Model LKCR1, LKCR5 (1999), 0 descendants of its own
- K960324: Hemagen CRP 150 Kit (Eia Method) (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K944288
Methodology: https://510kreport.com/methodology