CFA · Electrode, Ion Specific, Magnesium
Clinical Chemistry · 21 CFR 862.1495 · Class 1
Overview
| Product Code | CFA |
|---|---|
| Device Name | Electrode, Ion Specific, Magnesium |
| Regulation | 21 CFR 862.1495 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
Classification Rationale
Class I.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K863267 | MAGNESIUM PROCEDURE | Data Medical Associates, Inc. | Sep 11, 1986 | SESE |
| K851514 | ULTRA-VIOLET GLUCOSE REAGENT | Bio-Analytics Laboratories, Inc. | May 20, 1985 | SESE |
Top Applicants
- Data Medical Associates, Inc. — 1 clearance
- Bio-Analytics Laboratories, Inc. — 1 clearance
