← Product Code [CEF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF) · K802592

# PARAGON SERUM PROTEIN ELECTROPHORESIS (K802592)

_Beckman Instruments, Inc. · CEF · Nov 12, 1980 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K802592

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [CEF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF.md)
- **Decision Date:** Nov 12, 1980
- **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/K802592](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K802592)

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