REVISED MAGNESIUM TEST ITEM NUMBER: SR1019
Device Facts
| Record ID | K890798 |
|---|---|
| Device Name | REVISED MAGNESIUM TEST ITEM NUMBER: SR1019 |
| Applicant | Em Diagnostic Systems, Inc. |
| Product Code | JGJ · Clinical Chemistry |
| Decision Date | Mar 31, 1989 |
| 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).
