JGM · Flame Photometry, Potassium
Clinical Chemistry · 21 CFR 862.1600 · Class 2
Overview
| Product Code | JGM |
|---|---|
| Device Name | Flame Photometry, Potassium |
| Regulation | 21 CFR 862.1600 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Classification Rationale
Class II.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K895718 | LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER | Data Medical Associates, Inc. | Oct 19, 1989 | SESE |
| K862300 | AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT | Amresco, Inc. | Jul 29, 1986 | SESE |
| K831300 | MSI-NAK-50 TEST KIT | Medical Specialties, Inc. | Jul 18, 1983 | SESE |
| K810253 | SODIUM & POTASSIUM TEST KIT | Mallinckrodt Critical Care | Feb 10, 1981 | SESE |
| K771068 | TRIGLYCERIDE KIT | Environmental Chemical Specialties | Jul 12, 1977 | SESE |
Top Applicants
- Medical Specialties, Inc. — 1 clearance
- Mallinckrodt Critical Care — 1 clearance
- Environmental Chemical Specialties — 1 clearance
- Data Medical Associates, Inc. — 1 clearance
- Amresco, Inc. — 1 clearance
