FDA Registration
Active
🇺🇸 United States
POPS! one Blood Glucose Monitoring System
Reg #: 3013611320
·
FEI: 3013611320
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- POPS! DIABETES CARE, INC.
- Registration Number
- 3013611320
- FEI Number
- 3013611320
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 14060 Ozark Ave N
- City
- Stillwater
- State
- MN
- ZIP
- 55082
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181588
Owner / Operator
- Firm Name
- POPS! Diabetes Care, Inc.
- Operator Number
- 10059301
- Address
- 14060 Ozark Ave N
- City
- Stillwater
- State
- MN
- Postal Code
- 55082
- Country
- US
- Correspondent
- Lonny Stormo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2018-12-19 |
Proprietary Names
POPS! one Blood Glucose Monitoring System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198