Assay, Porphyrin, Spectrophotometry, Lithium
The Assay, Porphyrin, Spectrophotometry, Lithium (product code NDW) is an in vitro diagnostic assay that uses spectrophotometric methods to measure porphyrin levels associated with lithium exposure, used in clinical toxicology to assess zinc protoporphyrin or related analytes. It is an FDA Class 2 device within the Clinical Toxicology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NDW
- Device Class
- FDA class 2
- Regulation Number
- 862.3560
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243462 | Diazyme Colorimetric Lithium Assay | Aug 01, 2025 | Substantially Equivalent | Diazyme Laboratories, Inc. |
| K112142 | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE | Nov 04, 2011 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K063684 | COBAS LITHIUM | Mar 21, 2008 | Substantially Equivalent | Roche Diagnostics Corp. |
| K063705 | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL | Oct 09, 2007 | Substantially Equivalent | Thermo Electron OY |
| K070987 | SENTINEL LITHIUM ASSAY | Aug 02, 2007 | Substantially Equivalent | SENTINEL CH. SpA |
| K050374 | ADVIA IMS LITHIUM ASSAY | Jun 15, 2005 | Substantially Equivalent | Bayer Healthcare, LLC |
| K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | Jan 17, 2001 | Substantially Equivalent | Trace America, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.