FDA 510(k) Applications for Medical Device Product Code: DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control)

FDA 510(k) Applications for Medical Device Product Code "DEM"
(Alpha-1-Antitrypsin, Antigen, Antiserum, Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K031857	BAYER DIAGNOSTICS CORP.	ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY	09/04/2003
K964766	BECKMAN INSTRUMENTS, INC.	IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)	04/25/1997
K050596	BIOKIT S.A.	QUANTIA A1-AT	05/13/2005
K972640	BOEHRINGER MANNHEIM CORP.	TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY	01/09/1998
K965100	CRESTAT DIAGNOSTICS, INC.	N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT	07/14/1997
K063610	DADE BEHRING, INC.	DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH	01/11/2007
K053072	DADE BEHRING, INC.	N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN	03/28/2006
K993444	KAMIYA BIOMEDICAL CO.	K-ASSAY ALPHA-1 AT	11/24/1999
K052819	Ortho-Clinical Diagnostics, Inc.	VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III	12/23/2005
K010978	ROCHDIAG	TINA-QUANT ALPHA-1 ANTITRYPSIN	05/18/2001
K123256	THE BINDING SITE GROUP, LTD.	HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS	07/03/2013
K011663	THE BINDING SITE, LTD.	MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS	07/30/2001
K973391	VENTANA MEDICAL SYSTEMS, INC.	CHEMMATE KAPPA	10/03/1997
K973390	VENTANA MEDICAL SYSTEMS, INC.	CHEMMATE L26 (CD20)	10/03/1997
K973392	VENTANA MEDICAL SYSTEMS, INC.	CHEMMATE LAMBDA	10/03/1997
K973389	VENTANA MEDICAL SYSTEMS, INC.	CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING	10/03/1997