Data / Medical devices / Assay, Porphyrin, Spectrophotometry, Lithium
Assay, Porphyrin, Spectrophotometry, Lithium (NDW): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Assay, Porphyrin, Spectrophotometry, Lithium (product code NDW, Class 2, 21 CFR 862.3560). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on August 1, 2025, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NDW
- Device class
- 2
- Regulation
- 862.3560
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 2 |
| Italy | 1 |
| Switzerland | 1 |
Makers of Assay, Porphyrin, Spectrophotometry, Lithium
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 2 | November 4, 2011 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer, Manufacturer | 1 | January 17, 2001 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | March 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Sentinel CH. SPA | Milano, Italy | Manufacturer | 1 | August 2, 2007 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | June 15, 2005 | 0 | 3 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.