FDA Registration
Active
🇺🇸 United States
ACUSTAR
Reg #: 1219738
·
FEI: 1219738
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- KMC SYSTEMS, INC.
- Registration Number
- 1219738
- FEI Number
- 1219738
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 220 DANIEL WEBSTER HWY.
- City
- Merrimack
- State
- NH
- ZIP
- 03054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K083518
Owner / Operator
- Firm Name
- KMC Systems
- Operator Number
- 9024188
- Address
- 220 DANIEL WEBSTER HWY., --
- City
- Merrimack
- State
- NH
- Postal Code
- 03054
- Country
- US
- Correspondent
- Andrew Sageman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Multipurpose For In Vitro Coagulation Studies | JPA | Class 2 | Hematology | No | 2013-02-06 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2013-02-06 |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | Class 2 | Hematology | No | 2013-02-06 |
Proprietary Names
ACUSTAR
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)