Product code JIH
- Device name
- Flame Photometry, Lithium
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3560
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050338 | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM | Akers Biosciences, Inc. | 2005-03-04 |
| K031579 | INSTAREAD LITHIUM SYSTEM | Akers Laboratories, Inc. | 2003-12-19 |
| K011033 | DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 | Dade Behring, Inc. | 2001-06-07 |
| K934106 | KODAK EKTACHEM DTSC II SLIDES (LI) | Eastman Kodak Company | 1994-04-25 |
| K924488 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) | Eastman Kodak Company | 1993-01-26 |
| K921403 | MODEL 654 ANALYZER | Ciba Corning Diagnostics Corp. | 1992-07-30 |
| K895465 | AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE | Baxter Healthcare Corp | 1989-12-27 |
| K894328 | TDX(R) LITES(TM) LITHIUM | Abbott Laboratories | 1989-11-13 |
| K830636 | POTASSIUM DILUENT | Shaban Mfg. Co. | 1983-04-05 |
| K800039 | LITHIUM DILUENT (1500 MM/E) | Gilford Diagnostics | 1980-01-21 |
| K771303 | FLAME PHOTOMETER MODEL 460 | Corning Medical & Scientific | 1977-08-22 |
| K770824 | FLAME PHOTOMETER MOLEL 4600, KDA | American Monitor Corp. | 1977-07-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811403015979 | Internal Filling Solution | Diamond Diagnostics Inc. | 2023-06-06 |
| 00811403010028 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | Diamond Diagnostics Inc. | 2023-06-05 |
| 00811403019892 | SmartLyte Electrolyte Analyzer | Diamond Diagnostics Inc. | 2023-06-05 |
| 00811403019984 | ProLyte Electrolyte Analyzer | Diamond Diagnostics Inc. | 2023-06-05 |
| 00386100004378 | EasyRA Analyzer (LIS) | MEDICA CORPORATION | 2019-02-14 |
| 00386100004385 | EasyRA Analyzer (ISE&LIS) | MEDICA CORPORATION | 2019-02-14 |
| 00386100002282 | ISE Reagent Pack | MEDICA CORPORATION | 2019-02-14 |
| 00386100003524 | Na/K/Li Analyzer | MEDICA CORPORATION | 2018-12-11 |
| 00386100002558 | EasyElectrolyte Reagent Module, Na/K/Li Analyzers | MEDICA CORPORATION | 2018-12-11 |
| 00386100002480 | Lithium Electrode | MEDICA CORPORATION | 2018-12-11 |
| 00386100001667 | ISE Lithium Electrode | MEDICA CORPORATION | 2018-12-11 |
| 00386100002886 | Lithium Na/K/Li Analyzer | MEDICA CORPORATION | 2018-12-04 |
| 00386100002909 | Na/K/Cl/Li Analyzer | MEDICA CORPORATION | 2018-12-04 |
| 00386100002916 | Na/K/Cl/Li Solution Pack | MEDICA CORPORATION | 2018-12-04 |
| 00386100002923 | Na/K/Cl/Li Solution Pack | MEDICA CORPORATION | 2018-12-04 |
| 00386100003074 | Na/K/Li Solution Pack | MEDICA CORPORATION | 2018-12-04 |
| 00386100003104 | Na/K/Li Solution Pack | MEDICA CORPORATION | 2018-12-04 |
| 00386100003005 | Lithium Electrode | MEDICA CORPORATION | 2018-11-08 |
| 00842768005367 | Dimension® Flex® reagent cartridge LI | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414451862 | RAPIDChem® 700 Lithium Sensor | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414451824 | RAPIDChem® 754 Na+K+Li+ Reagent Module | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630028795 | Roche 9180 Lithium Electrode | Roche Diagnostics GmbH | 2016-09-20 |
| 10758750009466 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 10758750004720 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |