Data / Medical devices / Canada / Tyros Biopharma Inc.
Tyros Biopharma Inc.: FDA-registered device maker in Laval Quebec, Canada, 2 510(k) clearances
Tyros Biopharma Inc. is registered with the FDA (registration 3014759506) in Laval Quebec, Canada. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014759506
- Address
- 4702 Louis-B.-Mayer Suite 305, Laval Quebec, Canada, H7P 0L9
- Owner or operator
- Tyros Biopharma Inc. (10059257)
- Roles
- Exporter to the US, Specification developer
- First device listed
- March 8, 2024
- Registered through
- 2026
- Brand names listed
- Easy@Home Urinary Tract Infection Test, Gynatrof
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 | Exporter to the US | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Specification developer | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| March 1, 2024 | K232040 | Gynatrof | NUC | Substantially Equivalent | Tyros Biopharma, Inc. | accessdata.fda.gov |
| October 12, 2007 | K063295 | ACON UTI URINARY TRACT INFECTION TEST STRIPS | LJX | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- All makers of Test, Urine Leukocyte
- All makers of Lubricant, Personal
Updated March 1, 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.