Data / Medical devices / Finland / Actim OY
Actim OY: FDA-registered device maker in Espoo Uusimaa, Finland, 1 510(k) clearance
Actim OY is registered with the FDA (registration 1000212994) in Espoo Uusimaa, Finland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 9, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000212994
- Address
- Klovinpellontie 3, Espoo Uusimaa, Finland, FI-02180
- 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 23, 2023 | 93845 | Class II | Ongoing | Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane | Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result. | accessdata.fda.gov |
Compare with other makers
Updated April 17, 2024. 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.