Data / Medical devices / Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) (JKC): 20 FDA-registered makers in 9 countries
20 establishments in 9 countries are registered with the FDA to make Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) (product code JKC, Class 1, 21 CFR 862.1245). 3 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on March 24, 2004, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JKC
- Device class
- 1
- Regulation
- 862.1245
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 4 |
| China | 3 |
| Czechia | 1 |
| United Kingdom | 1 |
| Spain | 1 |
| Canada | 1 |
| Belgium | 1 |
| Japan | 1 |
Makers of Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
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 |
|---|---|---|---|---|---|---|---|---|
| IMMUNOTECH s.r.o. | Prague Praha, Hlavni Mesto, Czechia | Manufacturer | 1 | September 10, 1996 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Manufacturer | 1 | April 26, 1994 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | April 26, 1994 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Chaska, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DEMEDITEC DIAGNOSTICS GmbH | KIEL-WELLSEE Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostics Biochem Canada, Inc. | London Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSource ImmunoAssays, SA | Louvain-La-Neuve Brabant Wallon, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ibl International GMBH | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | 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 | |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 24, 2004. 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.