Data / Medical devices / Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers (LTJ): 21 FDA-registered makers in 6 countries
21 establishments in 6 countries are registered with the FDA to make Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers (product code LTJ, Class 2, 21 CFR 866.6010). 9 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on January 5, 2026, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LTJ
- Device class
- 2
- Regulation
- 866.6010
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| South Korea | 2 |
| United Kingdom | 2 |
| Germany | 2 |
| Ireland | 2 |
| Japan | 1 |
Makers of Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
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 |
|---|---|---|---|---|---|---|---|---|
| Nanoentek Inc | Hwaseong Gyeonggi, South Korea | Complaint file establishment, Manufacturer | 2 | May 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| Nanoentek Inc | Seoul, South Korea | Specification developer | 2 | May 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | March 9, 2000 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 1 | March 9, 2000 | 0 | 0 | 0 | api.fda.gov |
| Qualigen, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | October 25, 2000 | 0 | 2 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | January 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 1 | January 5, 2026 | 0 | 1 | 0 | api.fda.gov |
| Abbott Ireland | Sligo, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerica | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujirebio Diagnostics, Inc. | Malvern, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer for export | 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 | |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 5, 2026. 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.