JIH — Flame Photometry, Lithium Class II
FDA product code JIH covers "Flame Photometry, Lithium", a Class II medical device regulated under 21 CFR 862.3560. Submissions are reviewed by the Clinical Toxicology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JIH
- Device Class
- Class II
- Regulation Number
- 862.3560
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050338 | akers biosciences | MODIFICATION TO: INSTAREAD LITHIUM SYSTEM | March 4, 2005 |
| K031579 | akers laboratories | INSTAREAD LITHIUM SYSTEM | December 19, 2003 |
| K011033 | dade behring | DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 | June 7, 2001 |
| K934106 | eastman kodak | KODAK EKTACHEM DTSC II SLIDES (LI) | April 25, 1994 |
| K924488 | eastman kodak | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) | January 26, 1993 |
| K921403 | ciba corning diagnostics | MODEL 654 ANALYZER | July 30, 1992 |
| K895465 | baxter healthcare | AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE | December 27, 1989 |
| K894328 | abbott laboratories | TDX(R) LITES(TM) LITHIUM | November 13, 1989 |
| K830636 | shaban mfg | POTASSIUM DILUENT | April 5, 1983 |
| K800039 | gilford diagnostics | LITHIUM DILUENT (1500 MM/E) | January 21, 1980 |
| K771303 | corning medical and scientific | FLAME PHOTOMETER MODEL 460 | August 22, 1977 |
| K770824 | american monitor | FLAME PHOTOMETER MOLEL 4600, KDA | July 15, 1977 |