Data / Medical devices / United States / Avails Medical, Inc.
Avails Medical, Inc.: FDA-registered device maker in Menlo Park, CA, United States, 1 510(k) clearance
Avails Medical, Inc. is registered with the FDA (registration 3035367039) in Menlo Park, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035367039
- Address
- 1080 OBrien Drive, Suite A, Menlo Park, CA, United States, 94025
- Owner or operator
- Avails Medical, Inc. (10092380)
- Roles
- Specification developer
- First device listed
- December 30, 2024
- Registered through
- 2026
- Brand names listed
- eQUANT System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing | QZX | 2 | Specification developer | accessdata.fda.gov |
| Susceptibility Test Discs, Antimicrobial | JTN | 2 | 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 8, 2024 | K231536 | eQUANT System | QZX | Substantially Equivalent | Avails Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 8, 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.