Data / Medical devices / Finland / Actim Oy Manufacturing Site
Actim Oy Manufacturing Site: FDA-registered device maker in Joensuu Pohjois-Karjala, Finland, 1 510(k) clearance
Actim Oy Manufacturing Site is registered with the FDA (registration 3013143953) in Joensuu Pohjois-Karjala, Finland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 9, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013143953
- Address
- Noljakantie 13, Joensuu Pohjois-Karjala, Finland, FI-80130
- Owner or operator
- Actim Oy (10048029)
- Roles
- Manufacturer
- First device listed
- November 28, 2014
- Registered through
- 2026
- Brand names listed
- Actim PROM, Actim PROM Controls
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Immunoassay, Insulin-Like Growth Factor Binding Protein-1 | OAM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 9, 2014 | K123986 | ACTIM PROM | OAM | Substantially Equivalent | Alere Scarborough, Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 9, 2014. 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.