← Product Code [JMZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMZ) · K844589

# OSMOLARITY STANDARDS (K844589)

_Rna Medical Corp. · JMZ · Mar 1, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMZ/K844589

## Device Facts

- **Applicant:** Rna Medical Corp.
- **Product Code:** [JMZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMZ.md)
- **Decision Date:** Mar 1, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1540
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An osmolality test system is a device intended to measure ionic and nonionic solute concentration in body fluids, such as serum and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, including kidney diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMZ/K844589](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMZ/K844589)

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