← Product Code [JJK](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK) · K863099

# ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT (K863099)

_Abbott Laboratories · JJK · Sep 16, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K863099

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [JJK](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJK.md)
- **Decision Date:** Sep 16, 1986
- **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/MI/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K863099](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94clinical-laboratory-instruments/JJK/K863099)

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