Data / Medical devices / Insulin Autoantibody Kit
Insulin Autoantibody Kit (OCN): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Insulin Autoantibody Kit (product code OCN, Class 2, 21 CFR 866.5660). 1 of them has 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 July 13, 2007, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OCN
- Device class
- 2
- Regulation
- 866.5660
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United Kingdom | 1 |
| United States | 1 |
| Austria | 1 |
Makers of Insulin Autoantibody Kit
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 |
|---|---|---|---|---|---|---|---|---|
| RSR Ltd. | Cardiff, United Kingdom | Manufacturer | 1 | July 13, 2007 | 0 | 0 | 0 | api.fda.gov |
| Eli Lilly and Company, Pharmaceutical Delivery Systems | Indianapolis, IN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics International GMBH | ALTHOFEN Karnten, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 13, 2007. 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.