Flame Photometry, Lithium
Flame Photometry for Lithium is a clinical toxicology test system employing flame photometric detection to measure lithium concentration in blood, used to monitor therapeutic drug levels in patients treated with lithium for bipolar disorder and other psychiatric conditions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JIH, regulated under 21 CFR 862.3560, within the Clinical Toxicology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JIH
- 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 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050338 | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM | Mar 04, 2005 | Substantially Equivalent | Akers Biosciences, Inc. |
| K031579 | INSTAREAD LITHIUM SYSTEM | Dec 19, 2003 | Substantially Equivalent | Akers Laboratories, Inc. |
| K011033 | DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 | Jun 07, 2001 | Substantially Equivalent | Dade Behring, Inc. |
| K934106 | KODAK EKTACHEM DTSC II SLIDES (LI) | Apr 25, 1994 | Substantially Equivalent | Eastman Kodak Company |
| K924488 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) | Jan 26, 1993 | Substantially Equivalent | Eastman Kodak Company |
| K921403 | MODEL 654 ANALYZER | Jul 30, 1992 | Substantially Equivalent | Ciba Corning Diagnostics Corp. |
| K895465 | AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE | Dec 27, 1989 | Substantially Equivalent | Baxter Healthcare Corp |
| K894328 | TDX(R) LITES(TM) LITHIUM | Nov 13, 1989 | Substantially Equivalent | Abbott Laboratories |
| K830636 | POTASSIUM DILUENT | Apr 05, 1983 | Substantially Equivalent | Shaban Mfg. Co. |
| K800039 | LITHIUM DILUENT (1500 MM/E) | Jan 21, 1980 | Substantially Equivalent | Gilford Diagnostics |
| K771303 | FLAME PHOTOMETER MODEL 460 | Aug 22, 1977 | Substantially Equivalent | Corning Medical & Scientific |
| K770824 | FLAME PHOTOMETER MOLEL 4600, KDA | Jul 15, 1977 | Substantially Equivalent | American Monitor Corp. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.