Data / Medical devices / United States / Renalytixai
Renalytixai: FDA-registered device maker in Long Island City, NY, United States, 1 510(k) clearance
Renalytixai is registered with the FDA (registration 3018739912) in Long Island City, NY, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 29, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018739912
- Address
- 30-02 48th Avenue Suite 150, Long Island City, NY, United States, 11101
- Owner or operator
- Renalytix (10081544)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- April 22, 2021
- Registered through
- 2026
- Brand names listed
- KidneyIntelX Collection Kit, UACR, kidneyintelX.dkd, kidneyintelX.dkd Collection Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prognostic Test For Assessment Of Chronic Kidney Disease Progression | QWZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 29, 2023 | DEN200052 | KidneyIntelX.dkd | QWZ | Unknown | Renalytix Ai, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Urine Collection Kit (Excludes Hiv Testing)
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
Updated June 29, 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.