← Product Code [JJM](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJM) · K832783

# MICRO-SAMPLE OSMOMETER 3M0 (K832783)

_Advanced Instruments, Inc. · JJM · Nov 28, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJM/K832783

## Device Facts

- **Applicant:** Advanced Instruments, Inc.
- **Product Code:** [JJM](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJM.md)
- **Decision Date:** Nov 28, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2730
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An osmometer for clinical use is a device intended to measure the osmotic pressure of body fluids. Osmotic pressure is the pressure required to prevent the passage of a solution with a lesser solute concentration into a solution with greater solute concentration when the two solutions are separated by a semipermeable membrane. The concentration of a solution affects its osmotic pressure, freezing point, and other physiochemical properties. Osmometers determine osmotic pressure by methods such as the measurement of the freezing point. Measurements obtained by this device are used in the diagnosis and treatment of body fluid disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJM/K832783](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJM/K832783)

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