FDA Registration
Active
🇺🇸 United States
Prompt Inoculation System-D
Reg #: 3009840089
·
FEI: 3009840089
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PLASTIKON HEALTHCARE
- Registration Number
- 3009840089
- FEI Number
- 3009840089
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3780 Greenway Cir
- City
- Lawrence
- State
- KS
- ZIP
- 66046
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221493
Owner / Operator
- Firm Name
- Plastikon Healthcare
- Operator Number
- 10042054
- Address
- 3780 Greenway Circle
- City
- Lawrence
- State
- KS
- Postal Code
- 66046
- Country
- US
- Correspondent
- Sandy L Dixon
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent/Device, Inoculum Calibration | LIE | Class 2 | Microbiology | No | 2023-09-30 |
Proprietary Names
Prompt Inoculation System-D
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)