MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK
Device Facts
| Record ID | K912321 |
|---|---|
| Device Name | MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK |
| Applicant | Nova Biomedical Corp. |
| Product Code | JGJ · Clinical Chemistry |
| Decision Date | Jun 17, 1991 |
| 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).
