Atomic Absorption, Lithium
Atomic Absorption for Lithium is a clinical toxicology test system using atomic absorption spectroscopy to precisely quantify lithium levels in blood or serum, used for therapeutic drug monitoring in patients receiving lithium therapy for psychiatric disorders. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JII, regulated under 21 CFR 862.3560, within the Clinical Toxicology medical specialty. This device is eligible for third-party 510(k) review.
Research product code JII in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JII
- Device Class
- FDA class 2
- Regulation Number
- 862.3560
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K082001 | DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B | Dec 05, 2008 | Substantially Equivalent | Diazyme Laboratories |
| K033360 | DIAZYME LITHIUM ENZYMATIC ASSAY KIT | Dec 23, 2003 | Substantially Equivalent | General Atomics |
| K912244 | UROTEST GPH | Nov 22, 1991 | Substantially Equivalent | In Wha Pharmaceutical Co., Ltd. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.