← Product Code [JJN](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJN) · K772176

# CYSTIC FIBROSIS TESTING INSTRUMENT (K772176)

_Laboratory Equipment Design Co. · JJN · Dec 20, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJN/K772176

## Device Facts

- **Applicant:** Laboratory Equipment Design Co.
- **Product Code:** [JJN](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJN.md)
- **Decision Date:** Dec 20, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2485
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An electrophoresis apparatus for clinical use is a device intended to separate molecules or particles, including plasma proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their net charge in specified buffered media. This device is used in conjunction with certain materials to measure a variety of analytes as an aid in the diagnosis and treatment of certain disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJN/K772176](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJN/K772176)

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