Data / Medical devices / Sweden / Fujirebio Diagnostics, AB
Fujirebio Diagnostics, AB: FDA-registered device maker in Gothenburg Vastra Gotaland, Sweden, 1 510(k) clearance
Fujirebio Diagnostics, AB is registered with the FDA (registration 3000125561) in Gothenburg Vastra Gotaland, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 5, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000125561
- Address
- Elof Lindalvs Gata 13, Gothenburg Vastra Gotaland, Sweden, 41455
- Owner or operator
- Fujirebio Diagnostics, Inc. (10022860)
- Roles
- Manufacturer
- First device listed
- December 2, 2010
- Registered through
- 2026
- Brand names listed
- AMH Controls, Fujirebio Diagnostics Tumor Marker Control
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 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 |
|---|---|---|---|---|---|---|
| October 5, 2010 | K101809 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 | JJY | Substantially Equivalent | Fujirebio Diagnostics,Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 5, 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.