Beckman Coulter Biotechnology (Suzhou) Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 2 device types.
Beckman Coulter Biotechnology (Suzhou) Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Flow Cytometric Reagents And Accessories., Flow Cytometric Test System For Hematopoietic Neoplasms. Its earliest product listing with the FDA dates from 2023.
Registration
| Registered name | Beckman Coulter Biotechnology (Suzhou) Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003244710 |
| FEI number | 3003244710 |
| Establishment type | Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 贝克曼库尔特生物科技（苏州）有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Units 101, 201, 301, Building 4 No. 218 Sangtian Street, BioBAY Sangtian Island |
| Postal code | 215025 |
| Country | China |
Group
Beckman Coulter Biotechnology (Suzhou) Co., Ltd. is one of 2 plants registered under BECKMAN COULTER, INC..
| Plant | City | Device types |
|---|---|---|
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | 4 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Flow Cytometric Reagents And Accessories. | Class 2 | ClearLLab 10C T Cell Tube, ClearLLab 10C B Cell Tube, ClearLLab 10C M1 Cell Tube, ClearLLab M2 Cell Tube, DxFLEX Flow Cytometer | 2023 | 1 |
| Flow Cytometric Test System For Hematopoietic Neoplasms | Class 2 | ClearLLab 10C T Cell Tube, ClearLLab 10C B Cell Tube, ClearLLab 10C M1 Cell Tube, ClearLLab M2 Cell Tube, DxFLEX Flow Cytometer | 2023 | 1 |
Clearances
No clearance names Beckman Coulter Biotechnology (Suzhou) Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232600 | 2023-11-22 | OYE | Traditional | Beckman Coulter, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1997 |
|---|---|
| Main products | S5000 automated sample processing, DxA 5000 laboratory automation, DxI 800 chemiluminescence immunoassay analyzer, AU5800 automatic biochemistry analyzer, DxH 900 hematology analyzer |
| Certifications | Medical device operation license |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.