JGT · Flame Photometry, Sodium
Clinical Chemistry · 21 CFR 862.1665 · Class 2
Overview
| Product Code | JGT |
|---|---|
| Device Name | Flame Photometry, Sodium |
| Regulation | 21 CFR 862.1665 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K896829 | TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) | Technicon Instruments Corp. | Feb 23, 1990 | SESE |
| K891574 | LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 | Em Diagnostic Systems, Inc. | Jun 9, 1989 | SESE |
| K841610 | COMPONENTS FOR POTASSIUM, SODIUM CHLO | Shaban Mfg. Co. | May 25, 1984 | SESE |
| K840216 | SODIUM/POTASSIUM REAGENT SYS | Sclavo, Inc. | Mar 19, 1984 | SESE |
| K834248 | PARALLEL FLAME PHOTOMETER & SODIUM | American Monitor Corp. | Jan 30, 1984 | SESE |
| K811886 | CESIUM DILUENT 7.5M | Gilford Diagnostics | Jul 23, 1981 | SESE |
| K801892 | KLINAR REAGENT PAK, #36010 | Hi Chem, Inc. | Oct 23, 1980 | SESE |
| K770774 | LYTETEK SYSTEM | Boehringer Mannheim Corp. | Jul 11, 1977 | SESE |
Top Applicants
- American Monitor Corp. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance
- Gilford Diagnostics — 1 clearance
- Hi Chem, Inc. — 1 clearance
