FDA 510(k) Applications for Medical Device Product Code: KFF (Assay, Heparin)

FDA 510(k) Applications for Medical Device Product Code "KFF"
(Assay, Heparin)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K013637	AMERICAN DIAGNOSTICA, INC.	ACTICHROME HEPARIN (ANTI-FIIA)	04/16/2002
K013318	AMERICAN DIAGNOSTICA, INC.	ACTICHROME HEPARIN (ANTI-FXA), MODEL 832	03/08/2002
K013305	CARDIOVASCULAR DIAGNOSTICS, INC.	ENOXAPARIN TEST CARD	08/23/2002
K111822	DIAGNOSTICA STAGO, INC.	STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH	10/26/2011
K010455	DIAGNOSTICA-STAGO	ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN	06/07/2001
K952667	HELENA LABORATORIES	CHROM Z-HEPARIN, CAT. NO 5242	02/14/1996
K050367	HYPHEN BIOMED	BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6	05/24/2006
K983178	INSTRUMENTATION LABORATORY CO.	COAMATIC HEPARIN	11/03/1998
K213464	Instrumentation Laboratory Co.	HemosIL Liquid Anti-Xa	10/04/2022
K090209	INSTRUMENTATION LABORATORY CO.	HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS	06/02/2009
K980242	INSTRUMENTATION LABORATORY CO.	IL TEST HEPARIN	03/19/1998
K010193	INTERNATIONAL TECHNIDYNE CORP.	HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS	06/06/2001
K972209	MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.	SPECTROLYSE HEPARIN (ANTI-IIA)	08/12/1997
K965076	ORGANON TEKNIKA CORP.	MDA HEPARIN ANTI-X ASSAY	03/18/1997
K162540	SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH	INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls	08/22/2017