← Product Code [CEF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF) · K913058

# REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 (K913058)

_Helena Laboratories · CEF · Oct 30, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K913058

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [CEF](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF.md)
- **Decision Date:** Oct 30, 1991
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K913058](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEF/K913058)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com