← Product Code [JJK](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK) · K823196

# SPECIAL CONTROL SERUM FOR HDL-CHOLES (K823196)

_Boehringer Mannheim Corp. · JJK · Nov 29, 1982 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K823196

## Device Facts

- **Applicant:** Boehringer Mannheim Corp.
- **Product Code:** [JJK](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK.md)
- **Decision Date:** Nov 29, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2720
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A plasma oncometer for clinical use is a device intended to measure plasma oncotic pressure, which is that portion of the total plasma osmotic pressure contributed by protein and other molecules too large to pass through a specified semipermeable membrane. Because variations in plasma oncotic pressure are indications of certain disorders, measurements of the variations are useful in the diagnosis and treatment of these disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K823196](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K823196)

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