DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
Device Facts
| Record ID | K011033 |
|---|---|
| Device Name | DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 |
| Applicant | Dade Behring, Inc. |
| Product Code | JIH · Clinical Toxicology |
| Decision Date | Jun 7, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3560 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
