Who else makes this device?

Name: George King Heparin Control Plasma
Brand: George King Heparin Control Plasma

Hematology › Automated Hematology DevicesPlasma, Coagulation Control

George King Heparin Control Plasma

George King (GK) Heparin Control Plasma is an assayed citrated plasma intended for the control of Unfractionated Heparin (UFH) activity using an anti-Xa chromogenic assay and coagulation…

Registry build 21.09.26

George King (GK) Heparin Control Plasma is an assayed citrated plasma intended for the control of Unfractionated Heparin (UFH) activity using an anti-Xa chromogenic assay and coagulation analyzer with appropriate commercial anti-Xa reagents.

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shandong (2), Shanghai (1).

Chinese manufacturers registered for FDA product code GGN
Manufacturer	City	Province	Registered as	Device types
Infitek Co., Ltd.	Shanghai	Shanghai	Manufacturer	49
Labpeak Co., Ltd.	Jinan	Shandong	Manufacturer	43
Scitek Global Co., Ltd.	Jinan	Shandong	Manufacturer	43

Record

Regulatory record for George King Heparin Control Plasma
Listed by	George King BIO-Medical, Inc., United States
FDA product code	GGN
Device type	Plasma, Coagulation Control
Device class	Class 2
Regulation	21 CFR 864.5425
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2025-07-11

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Special storage condition: -70°C or below

Catalogue Numbers

Catalogue numbers for George King Heparin Control Plasma
Catalogue number	Size	Status
7000-1.0		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
George King Pooled Normal Plasma	George King BIO-Medical, Inc.	15
directCHECK Whole Blood Controls	Accriva Diagnostics, Inc.	12
Thermo Scientific Pacific Hemostasis®	Fisher Diagnostics	8
Lyphochek	Bio-Rad Laboratories Inc.	8
George King Single Donor Normal Plasma	George King BIO-Medical, Inc.	7
Validate	LGC Clinical Diagnostics, Inc.	6
George King Coumadin® Plasma	George King BIO-Medical, Inc.	5
Plasma, Coagulation Control	Medtronic, Inc.	5
Liquichek	Bio-Rad Laboratories Inc.	5
CueSee® Coag	Eurotrol B.V.	5
Rotem®	TEM Innovations GmbH	4
CRYOcheck™ Pooled Normal Plasma	Precision BioLogic Inc.	4

Showing 12 of 129. All products under Plasma, Coagulation Control

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K161316	2017-02-23
K945855	1995-10-24
K945854	1995-10-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.