← Product Code [DHL](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/DHL) · K870351

# EZ COMPLEMENT REAGENTS, 78N2212 (K870351)

_Diamedix Corp. · DHL · Mar 13, 1987 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/DHL/K870351

## Device Facts

- **Applicant:** Diamedix Corp.
- **Product Code:** [DHL](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/DHL.md)
- **Decision Date:** Mar 13, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.4100
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/DHL/K870351](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/DHL/K870351)

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