← Product Code [DER](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER) · K854875

# APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (K854875)

_Photec Diagnostics, Inc. · DER · Jan 24, 1986 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K854875

## Device Facts

- **Applicant:** Photec Diagnostics, Inc.
- **Product Code:** [DER](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER.md)
- **Decision Date:** Jan 24, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5580
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K854875](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DER/K854875)

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