Data / Medical devices / United States / Trukera Medical
Trukera Medical: FDA-registered device maker in Temecula, CA, United States, 1 510(k) clearance
Trukera Medical is registered with the FDA (registration 3007137761) in Temecula, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 14, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007137761
- Address
- 42309 Winchester Rd Suite I, Temecula, CA, United States, 92590
- Owner or operator
- Trukera Medical (10026657)
- Roles
- Specification developer
- First device listed
- July 8, 2009
- Registered through
- 2026
- Brand names listed
- ScoutPro Osmolarity System, TearLab Osmolarity System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Osmolality Of Tears | OND | 1 | Specification developer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | 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 |
|---|---|---|---|---|---|---|
| May 14, 2009 | K083184 | TEARLAB OSMOLARITY SYSTEM | OND | Substantially Equivalent | Ocusense, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Osmolality Of Tears
Updated May 14, 2009. 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.