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) → KTQ — Reagent, Complement

# KTQ · Reagent, Complement

_Immunology · 21 CFR 866.4100 · Class 1_

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

## Overview

- **Product Code:** KTQ
- **Device Name:** Reagent, Complement
- **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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K890417](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/KTQ/K890417.md) | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | Atlantic Antibodies | Feb 17, 1989 | SESE |
| [K812522](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/KTQ/K812522.md) | RABBIT COMPLEMENT | Dutchland Laboratories, Inc. | Sep 23, 1981 | SESE |
| [K812370](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/KTQ/K812370.md) | GUINEA PIG COMPLEMENT REGULAR | Dutchland Laboratories, Inc. | Sep 8, 1981 | SESE |
| [K812369](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/KTQ/K812369.md) | GUINEA PIG COMPLEMENT VIRUS ANTIBODY | Dutchland Laboratories, Inc. | Sep 8, 1981 | SESE |
| [K791117](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/KTQ/K791117.md) | RABBIT COMPLEMENT | Calbiochem-Behring Corp. | Aug 3, 1979 | SESE |
| [K790380](https://fda.innolitics.com/submissions/IM/subpart-e%E2%80%94immunology-laboratory-equipment-and-reagents/KTQ/K790380.md) | LOW-TOX-H RABBIT COMPLEMENT | Cederlane Labs , Ltd. | Mar 21, 1979 | SESE |

## Top Applicants

- Dutchland Laboratories, Inc. — 3 clearances
- Atlantic Antibodies — 1 clearance
- Calbiochem-Behring Corp. — 1 clearance
- Cederlane Labs , Ltd. — 1 clearance

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

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