LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
Device Facts
| Record ID | K003583 |
|---|---|
| Device Name | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 |
| Applicant | Trace America, Inc. |
| Product Code | NDW · Clinical Toxicology |
| Decision Date | Jan 17, 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).
