Data / Medical devices / Netherlands / Beckman Coulter Distribution B.V.
Beckman Coulter Distribution B.V.: FDA-registered device maker in Woerden Utrecht, Netherlands, 1 510(k) clearance
Beckman Coulter Distribution B.V. is registered with the FDA (registration 3007750372) in Woerden Utrecht, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 1, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007750372
- Address
- Pelmolenlaan 15, Woerden Utrecht, Netherlands, 3447 GW
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Exporter to the US
- First device listed
- March 8, 2019
- Registered through
- 2026
- Brand names listed
- DxH 500 Hematology Analyzer (B40601), DxH 520 Hematology Analyzer (B40602), DxH 560 Hematology Analyzer (B40603)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Counter, Differential Cell | GKZ | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| March 1, 2019 | K181475 | DxH 520 Hematology Instrument | GKZ | Unknown | Beckman Coulter | accessdata.fda.gov |
Compare with other makers
Updated March 1, 2019. 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.