Data / Medical devices / United States / Siro Diagnostics, Inc.
Siro Diagnostics, Inc.: FDA-registered device maker in San Diego, CA, United States, 2 510(k) clearances
Siro Diagnostics, Inc. is registered with the FDA (registration 3034617817) in San Diego, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034617817
- Address
- 9877 Waples Street, San Diego, CA, United States, 92121
- Owner or operator
- Siro Diagnostics, Inc. (10092299)
- Roles
- Specification developer
- First device listed
- December 20, 2024
- Registered through
- 2026
- Brand names listed
- Siro Diagnostics COVID-19 Molecular Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens | QWB | 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 |
|---|---|---|---|---|---|---|
| November 28, 2023 | K232643 | Cue COVID-19 Molecular Test | QWB | Substantially Equivalent | Cue Health, Inc. | accessdata.fda.gov |
| June 6, 2023 | DEN220028 | Cue COVID-19 Molecular Test | QWB | Unknown | Cue Health, Inc. | accessdata.fda.gov |
Updated November 28, 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.