Data / Medical devices / United States / Qurasense, Inc.
Qurasense, Inc.: FDA-registered device maker in Menlo Park, CA, United States, 1 510(k) clearance
Qurasense, Inc. is registered with the FDA (registration 3023949424) in Menlo Park, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023949424
- Address
- 3517 Edison Way Ste. D, Menlo Park, CA, United States, 94025
- Owner or operator
- Qurasense, Inc. (10085929)
- Roles
- Manufacturer
- First device listed
- March 11, 2024
- Registered through
- 2026
- Brand names listed
- A1c Q-Pad Kit, Q-Pad Collection Kit, Q-Pad Kit, Q-Pad Test System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Glycosylated Hemoglobin | LCP | 2 | Manufacturer | accessdata.fda.gov |
| Menstrual Blood Collection Device | QZG | 2 | 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 |
|---|---|---|---|---|---|---|
| December 6, 2023 | K231465 | Q-Pad Test System | LCP | Substantially Equivalent | Qurasense | accessdata.fda.gov |
Compare with other makers
Updated December 6, 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.