← Product Code [CEF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF) · K781123

# PONCEAU S (K781123)

_Electrophoresis Corp. of America · CEF · Aug 10, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K781123

## Device Facts

- **Applicant:** Electrophoresis Corp. of America
- **Product Code:** [CEF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF.md)
- **Decision Date:** Aug 10, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1630
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A protein (fractionation) test system is a device intended to measure protein fractions in blood, urine, cerebrospinal fluid, and other body fluids. Protein fractionations are used as an aid in recognizing abnormal proteins in body fluids and genetic variants of proteins produced in diseases with tissue destruction.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K781123](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K781123)

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