Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5660](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5660) → OSK — Anti-Glutamate Receptor (Type Nmda) Ifa

# OSK · Anti-Glutamate Receptor (Type Nmda) Ifa

_Immunology · 21 CFR 866.5660 · Class 2_

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

## Overview

- **Product Code:** OSK
- **Device Name:** Anti-Glutamate Receptor (Type Nmda) Ifa
- **Regulation:** [21 CFR 866.5660](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5660)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K100017](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/OSK/K100017.md) | EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM | Euroimmun Us, Inc. | Sep 13, 2010 | SESE |

## Top Applicants

- Euroimmun Us, Inc. — 1 clearance

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

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