Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart E — Immunology Laboratory Equipment and Reagents](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents) → [21 CFR 866.4100](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4100) → DHL — Protein, Complement, Antigen, Antiserum, Control

# DHL · Protein, Complement, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.4100 · Class 1_

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

## Overview

- **Product Code:** DHL
- **Device Name:** Protein, Complement, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.4100](/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/866.4100)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K870351](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/DHL/K870351.md) | EZ COMPLEMENT REAGENTS, 78N2212 | Diamedix Corp. | Mar 13, 1987 | SESE |
| [K811445](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/DHL/K811445.md) | KALLESTAD R QUANTIPLATE ALT. PATHWAY T. | Kallestad Laboratories, Inc. | Jun 24, 1981 | SESE |
| [K811433](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/DHL/K811433.md) | SCRIPPSERA COMPLEMENT CONTROL SERA | Scripps-Miles, Inc. | Jun 16, 1981 | SESE |
| [K770866](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/DHL/K770866.md) | RABBIT COMPLEMENT | Cedarlake Labs , Ltd. | Jun 3, 1977 | SESE |

## Top Applicants

- Cedarlake Labs , Ltd. — 1 clearance
- Diamedix Corp. — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
- Scripps-Miles, Inc. — 1 clearance

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

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