GEM-PREMIER SYSTEM
Device Facts
| Record ID | K910305 |
|---|---|
| Device Name | GEM-PREMIER SYSTEM |
| Applicant | Mallinckrodt Sensor Systems, Inc. |
| Product Code | JGS · Clinical Chemistry |
| Decision Date | Apr 3, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1665 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
