OSMOLARITY STANDARDS
Device Facts
| Record ID | K844589 |
|---|---|
| Device Name | OSMOLARITY STANDARDS |
| Applicant | Rna Medical Corp. |
| Product Code | JMZ · Clinical Chemistry |
| Decision Date | Mar 1, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1540 |
| Device Class | Class 1 |
Regulatory Classification
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.
