Data / Medical devices / United States / Inflammatix
Inflammatix: FDA-registered device maker in Sunnyvale, CA, United States, 1 510(k) clearance
Inflammatix is registered with the FDA (registration 3022977716) in Sunnyvale, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022977716
- Address
- 540 Oakmead Pkwy, Sunnyvale, CA, United States, 94085
- Owner or operator
- Inflammatix () (10092481)
- Roles
- Manufacturer
- First device listed
- February 25, 2025
- Registered through
- 2026
- Brand names listed
- Myrna, TriVerity, TriVerity Mini Verification Panel, TriVerity Quality Control Level 1, TriVerity Quality Control Level 2, TriVerity Verification Panel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 | Manufacturer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Manufacturer | accessdata.fda.gov |
| Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers | PRE | 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 |
|---|---|---|---|---|---|---|
| January 10, 2025 | K241676 | TriVerity | PRE | Substantially Equivalent | Inflammatix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of Real Time Nucleic Acid Amplification System
- All makers of Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
Updated January 10, 2025. 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.