← Product Code [DCK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK) · K944288

# HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) (K944288)

_Hemagen Diagnostics, Inc. · DCK · Oct 3, 1994 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K944288

## Device Facts

- **Applicant:** Hemagen Diagnostics, Inc.
- **Product Code:** [DCK](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK.md)
- **Decision Date:** Oct 3, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5270
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K944288](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCK/K944288)

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