Data / Medical devices / United States / Vidan Diagnostics, LLC
Vidan Diagnostics, LLC: FDA-registered device maker in San Antonio, TX, United States, 1 510(k) clearance
Vidan Diagnostics, LLC is registered with the FDA (registration 3014353121) in San Antonio, TX, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 10, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014353121
- Address
- 24123 Boerne Stage R. Suite 205, San Antonio, TX, United States, 78255
- Owner or operator
- Vidan Diagnostics, LLC (10057257)
- Roles
- Repackager or relabeler
- First device listed
- March 13, 2018
- Registered through
- 2026
- Brand names listed
- Lucidplus B-ketone Plus Blood Glucose Monitoring System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Repackager or relabeler | 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 10, 2016 | K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems | NBW | Substantially Equivalent | Taidoc Technology Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Dehydrogenase, Glucose
Updated November 10, 2016. 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.