Onechipdx Biotech (Suzhou) Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 2 device types.
Onechipdx Biotech (Suzhou) Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Counter, Differential Cell, Control, Cell Counter, Normal And Abnormal. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | ONECHIPDX BIOTECH (SUZHOU) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3038625004 |
| FEI number | 3038625004 |
| Establishment type | Specification developer, Complaint-file establishment, Manufacturer |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Unit 302, A6 Bldg, Phase I Biomedical Industrial Park, No.218 Xinghu Str, Suzhou Industrial Park |
| Postal code | 215028 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Control, Cell Counter, Normal And Abnormal | Class 2 | CitoCBC Control | 2025 | 1 |
| Counter, Differential Cell | Class 2 | CitoCBC System | 2025 | 3 |
Clearances
No clearance names Onechipdx Biotech (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 |
|---|---|---|---|---|
| K240402 | 2025-02-03 | GKZ | Dual Track | Cytochip, Inc. |
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.