FDA 510(k) Applications for Medical Device Product Code: DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control)

FDA 510(k) Applications for Medical Device Product Code "DBA"
(Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K003747	BAXTER HEALTHCARE CORP.	C1-INHIBITOR MICROTITER ASSAY DEVICE	03/19/2001
K960257	BEHRING DIAGNOSTICS, INC.	N ANTISERUM TO C1 INHIBITOR	08/01/1996
K965024	CRESTAT DIAGNOSTICS, INC.	N-ASSAY TIA C1-INACTIVATOR TEST KIT	07/14/1997
K872426	CYTOTECH, INC.	CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY	07/23/1987
K072965	DADE BEHRING, INC.	DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON	12/21/2007
K780335	HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES	LAS-R HUMAN C1 ESTERASE INHIBITOR TEST	03/22/1978
K781017	ICL SCIENTIFIC	ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)	08/14/1978
K011780	KAMIYA BIOMEDICAL CO.	K-ASSAY C1-INA	07/25/2001
K951967	KENT LABORATORIES, INC.	HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT	05/30/1995
K821898	ORTHO DIAGNOSTIC SYSTEMS, INC.	ORTHO CLASSICAL PATHWAY COMPL. TEST	07/16/1982
K141100	THE BINDING SITE GROUP LTD	OPTILITE C1 INACTIVATOR KIT	07/18/2014
K122304	THE BINDING SITE GROUP, LTD.	HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS	04/15/2013
K915431	THE BINDING SITE, LTD.	COMPLEMENT C1 INACTIVATOR KIT	01/17/1992