FDA Registration
Active
🇺🇸 United States
SIMPLE DIAGNOSTICS
Reg #: 3007384659
·
FEI: 3007384659
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIMPLE DIAGNOSTICS
- Registration Number
- 3007384659
- FEI Number
- 3007384659
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 5208 Grand Ave, Suite 201
- City
- Maspeth
- State
- NY
- ZIP
- 11378
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191657
Owner / Operator
- Firm Name
- Simple Diagnostics
- Operator Number
- 10028449
- Address
- 52-08 Grand Ave, Suite 201
- City
- Maspeth
- State
- NY
- Postal Code
- 11378
- Country
- US
- Correspondent
- Muhammad arif
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2021-03-04 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198