JIH
12 FDA 510(k) clearances · Product code
107 daysmedian time to decision
213 days90th percentile
12clearances measured
FDA profile
- Official device name
- Flame Photometry, Lithium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3560
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2006: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (K050338) | Akers Biosciences, Inc. | 2005-03-04 |
| INSTAREAD LITHIUM SYSTEM (K031579) | Akers Laboratories, Inc. | 2003-12-19 |
| DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 (K011033) | Dade Behring, Inc. | 2001-06-07 |
| KODAK EKTACHEM DTSC II SLIDES (LI) (K934106) | Eastman Kodak Company | 1994-04-25 |
| KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) (K924488) | Eastman Kodak Company | 1993-01-26 |
| MODEL 654 ANALYZER (K921403) | Ciba Corning Diagnostics Corp. | 1992-07-30 |
| AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE (K895465) | Baxter Healthcare Corp | 1989-12-27 |
| TDX(R) LITES(TM) LITHIUM (K894328) | Abbott Laboratories | 1989-11-13 |
| POTASSIUM DILUENT (K830636) | Shaban Mfg. Co. | 1983-04-05 |
| LITHIUM DILUENT (1500 MM/E) (K800039) | Gilford Diagnostics | 1980-01-21 |
| FLAME PHOTOMETER MODEL 460 (K771303) | Corning Medical & Scientific | 1977-08-22 |
| FLAME PHOTOMETER MOLEL 4600, KDA (K770824) | American Monitor Corp. | 1977-07-15 |
Track JIH automatically
Every clearance here is in the API, with alerts when new ones post.