FDA 510(k) Applications for Medical Device Product Code: JBQ (Antithrombin Iii Quantitation)

FDA 510(k) Applications for Medical Device Product Code "JBQ"
(Antithrombin Iii Quantitation)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K974110	BECKMAN INSTRUMENTS, INC.	IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT	12/24/1997
K952515	CHROMOGENIX AB	COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY	01/23/1996
K043007	HYPHEN BIOMED	BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105	11/07/2005
K022195	INSTRUMENTATION LABORATORY CO.	COAMATIC AT-400	08/07/2002
K022550	INSTRUMENTATION LABORATORY CO.	COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS	08/27/2002
K070301	INSTRUMENTATION LABORATORY CO.	HEMOSIL ANTITHROMBIN	02/23/2007
K062431	INSTRUMENTATION LABORATORY CO.	HEMOSIL LIQUID ANTITHROMBIN	09/01/2006
K033775	INSTRUMENTATION LABORATORY CO.	HEMOSIL LIQUID ANTITHROMBIN XL	01/02/2004
K980499	INSTRUMENTATION LABORATORY CO.	IL TEST ANTITHROMBIN	04/02/1998
K994238	INSTRUMENTATION LABORATORY CO.	IL TEST LIQUID ANTITHROMBIN	06/23/2000
K000361	KAMIYA BIOMEDICAL CO.	K-ASSAY AT-III	04/26/2000
K960871	MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.	SPECTROLYSE ANTITHROMBIN III (ANTI-XA)	08/14/1996
K023991	PRECISION BIOLOGIC	CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50	04/28/2003
K242952	Siemens Healthcare Diagnostic Products GmbH	INNOVANCE Antithrombin	03/28/2025
K081769	SIEMENS HEALTHCARE DIAGNOSTICS	INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5	05/28/2009
K972144	SIGMA DIAGNOSTICS, INC.	SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III	07/25/1997