Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1928890

FEI Number

1928890

Entity Name

GEORGE KING BIO-MEDICAL, INC.

City/State/Country

OVERLAND PARK, KS, US

Establishment Address

11771 WEST 112TH ST., OVERLAND PARK, KS 66210, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GEORGE KING BIO-MEDICAL, INC. (Owner Number: 1928890)

Owner / Operator Contact Address

11771 WEST 112TH ST., --, Overland Park, KS 66210, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2018-04-02
GJT	Plasma, Coagulation Factor Deficient	Hematology	Class 2	864.7290	2008-03-04
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2008-03-04
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2017-12-21
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2008-03-04
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2008-03-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GEORGE KING BIO-MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K934605	American Bioproducts Co.	STAGO FACTOR V-DEFICIENT PLASMA	1994-03-01
K180486	Instrumentation Laboratory CO	HemosIL Factor XII Deficient Plasma	2018-03-22
K043459	Instrumentation Laboratory CO	HEMOSIL FACTOR XII DEFICIENT PLASMA	2005-02-09
K021022	Instrumentation Laboratory CO	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	2002-05-14
K113211	Instrumentation Laboratory CO	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	2012-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0514-2014	Instrumentation Laboratory Co.	2	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014	Instrumentation Laboratory Co.	2	HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014	Instrumentation Laboratory Co.	2	HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

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2245451	DIAGNOSTICA STAGO, INC.	PARSIPPANY, NJ, US
1181121	Fisher Diagnostics	MIDDLETOWN, VA, US
8043599	Precision BioLogic Inc.	Dartmouth Nova Scotia, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1928890. Last updated year: 2026. Please use registration number 1928890 when referencing this establishment in official correspondence.