Data / Medical devices / Control, Fecal Occult Blood
Control, Fecal Occult Blood (OSL): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Control, Fecal Occult Blood (product code OSL, Class 2, 21 CFR 864.6550). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on October 1, 2010, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OSL
- Device class
- 2
- Regulation
- 864.6550
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| Australia | 1 |
Makers of Control, Fecal Occult Blood
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 |
|---|---|---|---|---|---|---|---|---|
| Bionostics, Inc. | Devens, MA, United States | Manufacturer | 1 | October 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| Enterix Inc. | Edison, NJ, United States | Complaint file establishment, Specification developer | 1 | October 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| Enterix Pty Ltd. | NORTH RYDE New South Wales, Australia | Manufacturer | 1 | October 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| Bioteke Corporation (wuxi) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Lysun Biotechnology Co.ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victorch Meditek, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 1, 2010. 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.