← Product Code [DDB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB) · K850682

# 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (K850682)

_Kent Laboratories, Inc. · DDB · Nov 25, 1985 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K850682

## Device Facts

- **Applicant:** Kent Laboratories, Inc.
- **Product Code:** [DDB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB.md)
- **Decision Date:** Nov 25, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5210
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.

## 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/DDB/K850682](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDB/K850682)

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