Product code NDW
- Device name
- Assay, Porphyrin, Spectrophotometry, 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 |
|---|---|---|---|
| K243462 | Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. | 2025-08-01 |
| K112142 | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2011-11-04 |
| K063684 | COBAS LITHIUM | Roche Diagnostics Corp. | 2008-03-21 |
| K063705 | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL | Thermo Electron OY | 2007-10-09 |
| K070987 | SENTINEL LITHIUM ASSAY | SENTINEL CH. SpA | 2007-08-02 |
| K050374 | ADVIA IMS LITHIUM ASSAY | Bayer Healthcare, LLC | 2005-06-15 |
| K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | Trace America, Inc. | 2001-01-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00811403010691 | Lithium Electrode | Diamond Diagnostics Inc. | 2023-06-05 |
| 00630414288178 | ADVIA Chemistry Lithium_2 (LITH_2) reagents | Siemens Healthcare Diagnostics Inc. | 2020-11-27 |
| 00630414287935 | Atellica CH Lithium_2 (LITH_2) | Siemens Healthcare Diagnostics Inc. | 2020-11-27 |
| 07613336121382 | Lithium | Roche Diagnostics GmbH | 2020-03-05 |
| 00385480167291 | NOVA | NOVA BIOMEDICAL CORPORATION | 2017-04-24 |
| 00385480165013 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480157421 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480152129 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480152112 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480167284 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480539630 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480142441 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480141826 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480539647 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480136839 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 04015630921669 | Lithium | Roche Diagnostics GmbH | 2016-09-20 |
| 00385480131940 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 04015630032440 | Lithium Electrode | Roche Diagnostics GmbH | 2016-09-20 |
| 00385480128827 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480146180 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480095839 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480146173 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480142533 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480141789 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131964 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131957 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131438 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131414 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480127042 | NOVA/STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480112727 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |