← Product Code [CEF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF) · K893211

# REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 (K893211)

_Helena Laboratories · CEF · Jun 19, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K893211

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [CEF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF.md)
- **Decision Date:** Jun 19, 1989
- **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/K893211](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K893211)

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