# K960324: Hemagen CRP 150 Kit (Eia Method)

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Mar 12, 1996 after 49 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: 1 generation back to K944288 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944288: Hemagen C-Reactive Protein Kit (Eia Method), Hemagen Diagnostics, Inc. (1994) Summary page 1.

## Indications for use
This kit has been designed for the measurement of C-reactive protein in human serum and plasma. When used according to instructions, the kit is useful in measuring the acute phase responses in humans to infection, tissue damage and various inflammatory conditions.

Source page: https://510kreport.com/device/K960324
Methodology: https://510kreport.com/methodology