FDA Registration
Active
🇺🇸 United States
GEORGE KING BIO-MEDICAL, INC.
Reg #: 1928890
·
FEI: 1928890
·
Expires 2026
Products
4
Proprietary Names
15
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- GEORGE KING BIO-MEDICAL, INC.
- Registration Number
- 1928890
- FEI Number
- 1928890
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11771 WEST 112TH ST.
- City
- OVERLAND PARK
- State
- KS
- ZIP
- 66210
- Country
- US
Regulatory Submissions
- 510(k) Number
- K945855
Owner / Operator
- Firm Name
- GEORGE KING BIO-MEDICAL, INC.
- Operator Number
- 1928890
- Address
- 11771 WEST 112TH ST., --
- City
- Overland Park
- State
- KS
- Postal Code
- 66210
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Control, Plasma, Abnormal | GGC | Class 2 | Hematology | No | 2018-04-02 |
| Plasma, Coagulation Factor Deficient | GJT | Class 2 | Hematology | No | 2008-03-04 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2008-03-04 |
| Plasma, Control, Normal | GIZ | Class 2 | Hematology | No | 2018-04-02 |
Proprietary Names
von Willebrand Plasma
FVIII Deficient Plasma with Inhibitor
Coagulation Factor Deficient Plasma
A-FACT
George King Coumadin® Plasma
Positive Lupus Anticoagulant Plasma
Pooled Normal Plasma
FACT
Single Donor Normal Plasma
CORE Kit (Control of Range Evaluation Kit)
SysCOR 40 Control
SDN Control Kit
Heparin Control Plasma
CORE kit (Control of Range Evaluation)
B-FACT
Establishment Types
Manufacture Medical Device