← Product Code [JZG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG) · K940353

# BECKMAN BETA-2-MICROGLOBULIN (B2M) (K940353)

_Beckman Instruments, Inc. · JZG · Apr 21, 1994 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K940353

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [JZG](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG.md)
- **Decision Date:** Apr 21, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5630
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

## Special Controls

*Classification.* Class II (special 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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K940353](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JZG/K940353)

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