JIH · Flame Photometry, Lithium
Clinical Toxicology · 21 CFR 862.3560 · Class 2
Overview
| Product Code | JIH |
|---|---|
| Device Name | Flame Photometry, 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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050338 | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM | Akers Biosciences, Inc. | Mar 4, 2005 | SESE |
| K031579 | INSTAREAD LITHIUM SYSTEM | Akers Laboratories, Inc. | Dec 19, 2003 | SESE |
| K011033 | DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 | Dade Behring, Inc. | Jun 7, 2001 | SESE |
| K934106 | KODAK EKTACHEM DTSC II SLIDES (LI) | Eastman Kodak Company | Apr 25, 1994 | SESE |
| K924488 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) | Eastman Kodak Company | Jan 26, 1993 | SESE |
| K921403 | MODEL 654 ANALYZER | Ciba Corning Diagnostics Corp. | Jul 30, 1992 | SESE |
| K895465 | AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE | Baxter Healthcare Corp | Dec 27, 1989 | SESE |
| K894328 | TDX(R) LITES(TM) LITHIUM | Abbott Laboratories | Nov 13, 1989 | SESE |
| K830636 | POTASSIUM DILUENT | Shaban Mfg. Co. | Apr 5, 1983 | SESE |
| K800039 | LITHIUM DILUENT (1500 MM/E) | Gilford Diagnostics | Jan 21, 1980 | SESE |
| K771303 | FLAME PHOTOMETER MODEL 460 | Corning Medical & Scientific | Aug 22, 1977 | SESE |
| K770824 | FLAME PHOTOMETER MOLEL 4600, KDA | American Monitor Corp. | Jul 15, 1977 | SESE |
Top Applicants
- Eastman Kodak Company — 2 clearances
- Abbott Laboratories — 1 clearance
- Akers Biosciences, Inc. — 1 clearance
- Akers Laboratories, Inc. — 1 clearance
- American Monitor Corp. — 1 clearance
