ROCHE REAGENT FOR MAGNESIUM
Device Facts
| Record ID | K901758 |
|---|---|
| Device Name | ROCHE REAGENT FOR MAGNESIUM |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | JGJ · Clinical Chemistry |
| Decision Date | May 23, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1495 |
| Device Class | Class 1 |
Regulatory Classification
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).
