FDA Registration
Active
🇺🇸 United States
TULA HEALTH, INC.
Reg #: 3017086896
·
FEI: 3017086896
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- TULA HEALTH, INC.
- Registration Number
- 3017086896
- FEI Number
- 3017086896
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 686 N Arbinger Way
- City
- Farmington
- State
- UT
- ZIP
- 84025
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162382
Owner / Operator
- Firm Name
- Tula Health, Inc.
- Operator Number
- 10076073
- Address
- 686 North Arbinger Way, Suite 300
- City
- Farmington
- State
- UT
- Postal Code
- 84025
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Glucose Dehydrogenase, Glucose | LFR | Class 2 | Clinical Chemistry | No | 2020-07-07 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2020-07-07 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2020-07-07 |
Proprietary Names
Live Tula Test Strips
Establishment Types
Repack or Relabel Medical Device