FDA Registration
Active
🇺🇸 United States
Rapid Diagnostic Tests
Reg #: 3030648160
·
FEI: 3030648160
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ASSURE TECH LLC
- Registration Number
- 3030648160
- FEI Number
- 3030648160
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1521 Concord Pike Suite 201
- City
- Wilmington
- State
- DE
- ZIP
- 19803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161044
Owner / Operator
- Firm Name
- Assure Tech LLC
- Operator Number
- 10090182
- Address
- 1521 Concord Pike Suite 201
- City
- Wilmington
- State
- DE
- Postal Code
- 19803
- Country
- US
- Correspondent
- Allen Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2024-03-07 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2024-03-07 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2024-03-07 |
Proprietary Names
Rapid Diagnostic Tests
Establishment Types
Repack or Relabel Medical Device