FDA 510(k) Applications for Medical Device Product Code: JBP (Activated Whole Blood Clotting Time)

FDA 510(k) Applications for Medical Device Product Code "JBP"
(Activated Whole Blood Clotting Time)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K964609	ARRAY MEDICAL, INC.	ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE	03/06/1997
K983649	ARRAY MEDICAL, INC.	MAX-ACT	12/11/1998
K971935	B & D CORP.	B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)	10/01/1997
K994194	CARDIOVASCULAR DIAGNOSTICS, INC.	(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT	03/28/2000
K062604	HAEMOSCOPE CORP.	RAPIDTEG TEG-ACT TEST	01/31/2007
K013078	HELENA LABORATORIES	ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752	01/10/2002
K020914	HELENA LABORATORIES	ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770	05/23/2002
K992571	I-STAT CORP.	I-STAT SYSTEM	02/10/2000
K023582	I-STAT CORPORATION	I-STAT KAOLIN ACT TEST	09/08/2003
K960749	INTERNATIONAL TECHNIDYNE CORP.	HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT	08/12/1996
K992851	ROCHE DIAGNOSTICS CORP.	ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM	01/14/2000
K032952	SIENCO, INC.	AIACT KIT	12/12/2003
K984141	SIENCO, INC.	GBACT + KIT	05/28/1999
K002528	SIENCO, INC.	SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION	08/31/2000
K223635	Sienco, Inc.	Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer	01/04/2023