Data / Medical devices / United States / George King Bio-Medical, Inc.
George King Bio-Medical, Inc.: FDA-registered device maker in Overland Park, KS, United States, 4 510(k) clearances
George King Bio-Medical, Inc. is registered with the FDA (registration 1928890) in Overland Park, KS, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 23, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1928890
- Address
- 11771 West 112TH ST., Overland Park, KS, United States, 66210
- Owner or operator
- GEORGE KING BIO-MEDICAL, INC. (1928890)
- Roles
- Manufacturer
- First device listed
- March 4, 2008
- Registered through
- 2026
- Brand names listed
- A-FACT, B-FACT, CORE Kit (Control of Range Evaluation Kit), CORE kit (Control of Range Evaluation), Coagulation Factor Deficient Plasma, FACT, FVIII Deficient Plasma with Inhibitor, George King Coumadin® Plasma and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Plasma, Abnormal | GGC | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Control | GGN | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Factor Deficient | GJT | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Control, Normal | GIZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2017 | K161316 | George King Coumadin Plasma | GGN | Substantially Equivalent | George King Bio-Medical, Inc. | accessdata.fda.gov |
| October 24, 1995 | K945855 | A-FACT, ABNORMAL FACTOR ASSAY CONTROL | GGN | Substantially Equivalent | George King Bio-Medical, Inc. | accessdata.fda.gov |
| October 24, 1995 | K945854 | B-FACT, BORDERLINE FACTOR ASSAY CONTROL | GGN | Substantially Equivalent | George King Bio-Medical, Inc. | accessdata.fda.gov |
| October 5, 1995 | K945856 | POSITIVE LUPUS ANTICOAGULANT PLASMA | GGC | Substantially Equivalent | George King Bio-Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Control, Plasma, Abnormal
- All makers of Plasma, Coagulation Control
- All makers of Plasma, Control, Normal
- All makers of Plasma, Coagulation Factor Deficient
Updated February 23, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.