← Product Code [DCK](/productcode/DCK) · K791560

# GOAT ANTI-HUMAN C-REACTIVE PROTEIN (K791560)

_Protos Laboratories · DCK · Sep 24, 1979 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K791560

## Device Facts

- **Applicant:** Protos Laboratories
- **Product Code:** [DCK](/productcode/DCK.md)
- **Decision Date:** Sep 24, 1979
- **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-staging.innolitics.com/device/K791560](https://fda-staging.innolitics.com/device/K791560)

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