FDA Registration
Active
🇺🇸 United States
Lucidplus B-ketone Plus Blood Glucose Monitoring System
Reg #: 3014353121
·
FEI: 3014353121
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- VIDAN DIAGNOSTICS, LLC
- Registration Number
- 3014353121
- FEI Number
- 3014353121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 24123 Boerne Stage R. Suite 205
- City
- San Antonio
- State
- TX
- ZIP
- 78255
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161738
Owner / Operator
- Firm Name
- Vidan Diagnostics, LLC
- Operator Number
- 10057257
- Address
- 24123 Boerne Stage R. Suite 205
- City
- San Antonio
- State
- TX
- Postal Code
- 78255
- Country
- US
- Correspondent
- Gilbert A Mejia
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2018-03-13 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2018-03-13 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-03-13 |
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2018-03-13 |
Proprietary Names
Lucidplus B-ketone Plus Blood Glucose Monitoring System
Establishment Types
Repack or Relabel Medical Device