Data / Medical devices / Flame Photometry, Lithium
Flame Photometry, Lithium (JIH): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Flame Photometry, Lithium (product code JIH, Class 2, 21 CFR 862.3560). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on March 4, 2005, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JIH
- Device class
- 2
- Regulation
- 862.3560
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Hungary | 1 |
| Switzerland | 1 |
Makers of Flame Photometry, 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 |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | January 26, 1993 | 0 | 2 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | January 26, 1993 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 1 | June 7, 2001 | 0 | 0 | 0 | api.fda.gov |
| DIAMOND DIAGNOSTICS Inc | Holliston, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diamond Diagnostics Inc. | Budapest, Hungary | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 4, 2005. 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.