← Product Code [CEQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEQ) · K863071

# PHOSPHOLIPIDS-E (K863071)

_J. D. Assoc. · CEQ · Sep 9, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEQ/K863071

## Device Facts

- **Applicant:** J. D. Assoc.
- **Product Code:** [CEQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEQ.md)
- **Decision Date:** Sep 9, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1575
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A phospholipid test system is a device intended to measure phospholipids in serum and plasma. Measurements of phospholipids are used in the diagnosis and treatment of disorders involving lipid (fat) metabolism.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEQ/K863071](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEQ/K863071)

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