NDW
7 FDA 510(k) clearances · Product code
121 daysmedian time to decision
465 days90th percentile
7clearances measured
FDA profile
- Official device name
- Assay, Porphyrin, Spectrophotometry, Lithium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3560
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Diazyme Colorimetric Lithium Assay (K243462) | Diazyme Laboratories, Inc. | 2025-08-01 |
| DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE (K112142) | Siemens Healthcare Diagnostics | 2011-11-04 |
| COBAS LITHIUM (K063684) | Roche Diagnostics Corp. | 2008-03-21 |
| LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL (K063705) | Thermo Electron OY | 2007-10-09 |
| SENTINEL LITHIUM ASSAY (K070987) | SENTINEL CH. SpA | 2007-08-02 |
| ADVIA IMS LITHIUM ASSAY (K050374) | Bayer Healthcare, LLC | 2005-06-15 |
| LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (K003583) | Trace America, Inc. | 2001-01-17 |
Track NDW automatically
Every clearance here is in the API, with alerts when new ones post.