Data / Medical devices / China / Beckman Coulter Biotechnology (Suzhou) Co., Ltd
Beckman Coulter Biotechnology (Suzhou) Co., Ltd: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Beckman Coulter Biotechnology (Suzhou) Co., Ltd is registered with the FDA (registration 3003244710) in Suzhou Jiangsu, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 22, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003244710
- Address
- Units 101, 201, 301, Building 4 No. 218 Sangtian Street, BioBAY Sangtian Island Suzhou Industrial Park, Suzhou Jiangsu, China, 215025
- Owner or operator
- BECKMAN COULTER, INC. (2050012)
- Roles
- Specification developer
- First device listed
- December 13, 2023
- Registered through
- 2026
- Brand names listed
- ClearLLab 10C T Cell Tube, ClearLLab 10C B Cell Tube, ClearLLab 10C M1 Cell Tube, ClearLLab M2 Cell Tube, DxFLEX Flow Cytometer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flow Cytometric Reagents And Accessories. | OYE | 2 | Specification developer | accessdata.fda.gov |
| Flow Cytometric Test System For Hematopoietic Neoplasms | PWD | 2 | 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 |
|---|---|---|---|---|---|---|
| November 22, 2023 | K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | OYE | Substantially Equivalent | Beckman Coulter, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Flow Cytometric Test System For Hematopoietic Neoplasms
- All makers of Flow Cytometric Reagents And Accessories.
Updated November 22, 2023. 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.