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


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