510(k) K243462
- Device
- Diazyme Colorimetric Lithium Assay
- Applicant
- Diazyme Laboratories, Inc.
- 510(k) number
- K243462
- Product code
- NDW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-01
- Date received
- 2024-11-08
- Regulation
- 862.3560
- Classification name
- Assay, Porphyrin, Spectrophotometry, Lithium
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Abhijit Datta
- Address
- 12889 Gregg Ct. Poway CA US 92130 92130
FDA Registration Numbers#
- 9610126
- 3006198300
- 2432235
- 3002809144
- 3003795116
- 1181121
- 2517506
- 3005333358
- 9681753
- 9610529
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NDW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |