JII · Atomic Absorption, Lithium
Clinical Toxicology · 21 CFR 862.3560 · Class 2
Overview
| Product Code | JII |
|---|---|
| Device Name | Atomic Absorption, Lithium |
| Regulation | 21 CFR 862.3560 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K082001 | DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B | Diazyme Laboratories | Dec 5, 2008 | SESE |
| K033360 | DIAZYME LITHIUM ENZYMATIC ASSAY KIT | General Atomics | Dec 23, 2003 | SESE |
| K912244 | UROTEST GPH | In Wha Pharmaceutical Co., Ltd. | Nov 22, 1991 | SESE |
Top Applicants
- Diazyme Laboratories — 1 clearance
- General Atomics — 1 clearance
- In Wha Pharmaceutical Co., Ltd. — 1 clearance
