Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5065](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5065) → DHY — Ng4m(A), Antigen, Antiserum, Control

# DHY · Ng4m(A), Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5065 · Class 1_

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

## Overview

- **Product Code:** DHY
- **Device Name:** Ng4m(A), Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5065](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5065)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A human allotypic marker immunological test system is a device that consists of the reagents used to identify by immunochemical techniques the inherited human protein allotypic markers (such as nGm, nA2 m, and Km allotypes) in serum and other body fluids. The identification may be used while studying population genetics.

## 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 § 866.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K810871](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHY/K810871.md) | LIGHTNING DIALYZER | Clintox Laboratories, Inc. | Jul 10, 1981 | SESE |

## Top Applicants

- Clintox Laboratories, Inc. — 1 clearance

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

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