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 |