Data / Medical devices / Taiwan / Jellox Biotech Inc.
Jellox Biotech Inc.: FDA-registered device maker in Hsinchu County Hsinchu(County), Taiwan, 1 510(k) clearance
Jellox Biotech Inc. is registered with the FDA (registration 3026040791) in Hsinchu County Hsinchu(County), Taiwan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 28, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026040791
- Address
- No. 66-5, Shengyi 5th Rd., Zhubei City, Hsinchu County Hsinchu(County), Taiwan, 302041
- Owner or operator
- JelloX Biotech Inc. (10086723)
- Roles
- Manufacturer
- First device listed
- December 5, 2022
- Registered through
- 2026
- Brand names listed
- JXClear DX, JelloScope DX, MetaLite DX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Clearing | KEM | 1 | Manufacturer | accessdata.fda.gov |
| Digital Pathology Image Viewing And Management Software | QKQ | 2 | Manufacturer | accessdata.fda.gov |
| Microscope, Fluorescence/U.V. | IBK | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 28, 2024 | K240303 | MetaLite DX Digital Pathology Software | QKQ | Substantially Equivalent | Jellox Biotech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Digital Pathology Image Viewing And Management Software
- All makers of Agent, Clearing
- All makers of Microscope, Fluorescence/U.V.
Updated October 28, 2024. 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.