FDA 510(k) Applications for Medical Device Product Code: DBI (Complement C4, Antigen, Antiserum, Control)

FDA 510(k) Applications for Medical Device Product Code "DBI"
(Complement C4, Antigen, Antiserum, Control)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K983356	ABBOTT LABORATORIES	C4	11/04/1998
K964297	CRESTAT DIAGNOSTICS, INC.	N-ASSAY TIA C4 TEST KIT	07/14/1997
K964300	CRESTAT DIAGNOSTICS, INC.	N-ASSAY TIA MULTI V-NL	07/14/1997
K994293	DADE BEHRING, INC.	DIMENSION C4 FLEX REAGENT CARTRIDGE	03/01/2000
K962198	INSTRUMENTATION LABORATORY CO.	QUANTEX C4	09/26/1996
K993481	KAMIYA BIOMEDICAL CO.	K-ASSAY C4	11/29/1999
K962582	OLYMPUS AMERICA, INC.	OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT	10/18/1996
K000468	RANDOX LABORATORIES, LTD.	RANDOX COMPLEMENT C4	03/27/2000
K012359	ROCHE DIAGNOSTICS CORP.	TINA-QUANT COMPLEMENT C4 TEST SYSTEM	11/29/2001
K100455	THE BINDING SITE	SPAPLUS ANALYZER	09/03/2010
K981785	THE BINDING SITE, LTD.	C4 MININEPH ANTISERUM	12/20/1999
K010325	WAKO CHEMICALS, USA, INC.	WAKO AUTOKIT C4	06/25/2001