JMZ · Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Clinical Chemistry · 21 CFR 862.1540 · Class 1
Overview
| Product Code | JMZ |
|---|---|
| Device Name | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality |
| Regulation | 21 CFR 862.1540 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K843680 | URI-VAL | Cenogenics Corp. | Mar 29, 1985 | SESE |
| K844589 | OSMOLARITY STANDARDS | Rna Medical Corp. | Mar 1, 1985 | SESE |
Top Applicants
- Cenogenics Corp. — 1 clearance
- Rna Medical Corp. — 1 clearance
