NDW — Assay, Porphyrin, Spectrophotometry, Lithium Class II
FDA Device Classification
Classification Details
- Product Code
- NDW
- 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 |
|---|
| K243462 | diazyme laboratories | Diazyme Colorimetric Lithium Assay | August 1, 2025 |
| K112142 | siemens healthcare diagnostics | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE | November 4, 2011 |
| K063684 | roche diagnostics | COBAS LITHIUM | March 21, 2008 |
| K063705 | thermo electron | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CA | October 9, 2007 |
| K070987 | sentinel ch | SENTINEL LITHIUM ASSAY | August 2, 2007 |
| K050374 | bayer healthcare | ADVIA IMS LITHIUM ASSAY | June 15, 2005 |
| K003583 | trace america | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | January 17, 2001 |