Data / Medical devices / China / Onechipdx Biotech (suzhou) Co., Ltd
Onechipdx Biotech (suzhou) Co., Ltd: FDA-registered device maker in Suzhou Jiangsu, China, 1 510(k) clearance
Onechipdx Biotech (suzhou) Co., Ltd is registered with the FDA (registration 3038625004) in Suzhou Jiangsu, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 3, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3038625004
- Address
- Unit 302, A6 Bldg, Phase I Biomedical Industrial Park, No.218 Xinghu Str, Suzhou Industrial Park, Suzhou Jiangsu, China, 215028
- Owner or operator
- CytoChip Inc. (10093532)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 29, 2025
- Registered through
- 2027
- Brand names listed
- CitoCBC Control, CitoCBC System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Cell Counter, Normal And Abnormal | JCN | 2 | Specification developer | accessdata.fda.gov |
| Counter, Differential Cell | GKZ | 2 | Complaint file establishment, Manufacturer, 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, 2025 | K240402 | Cito CBC System | GKZ | Substantially Equivalent | Cytochip, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 3, 2025. 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.