Data / Medical devices / Sweden / Boule Medical AB
Boule Medical AB: FDA-registered device maker in Spanga Stockholm, Sweden, 1 510(k) clearance
Boule Medical AB is registered with the FDA (registration 3004008703) in Spanga Stockholm, Sweden. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 3, 2009. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004008703
- Address
- Fagerstagatan 7, Spanga Stockholm, Sweden, 163 53
- Owner or operator
- Boule Diagnostics AB (9034165)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- June 4, 1999
- Registered through
- 2027
- Brand names listed
- 501-002 ENZYMATIC CLEANER, 501-003 HEMATOLOGY DILUENT, 501-029 Ac.T Cleaner and Shutdown Solution, 501-032 ENZYMATIC CLEANER, 501-036 Boule Cleaning Kit, 501-052 CDS Hematology Diluent, 501-056 CDS Hematology Diluent, 501-057 CDS Hematology Diluent and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Counter, Differential Cell | GKZ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Detergent | JCB | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Diluent, Blood Cell | GIF | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Products, Red-Cell Lysing Products | GGK | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Tube, Collection, Capillary Blood | GIO | 1 | Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 3, 2009 | K083420 | MEDONIC M SERIES | GKZ | Substantially Equivalent | Boule Medical AB | accessdata.fda.gov |
Compare with other makers
- All makers of Diluent, Blood Cell
- All makers of Counter, Differential Cell
- All makers of Detergent
- All makers of Products, Red-Cell Lysing Products
- All makers of Tube, Collection, Capillary Blood
Updated February 3, 2009. 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.