FDA 510(k) Applications for Medical Device Product Code "DEB"
(Alpha-2-Macroglobulin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K850603 APPLICATIONS LAB SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN 03/05/1985
K791340 BECKMAN INSTRUMENTS, INC. HUMAN ALPHA2 MACROGLOBULIN 08/16/1979
K974564 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT 02/17/1998
K851282 COOPER BIOMEDICAL, INC. RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI 05/24/1985
K081249 DADE BEHRING, INC. DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM 07/21/2008
K053073 DADE BEHRING, INC. N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN 03/28/2006
K812493 DAKO CORP. IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO 09/23/1981
K771780 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R TM 10/04/1977
K896483 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK 12/01/1989
K772246 KALLESTAD LABORATORIES, INC. ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY 12/22/1977
K850683 KENT LABORATORIES, INC. 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 11/27/1985
K140664 THE BINDING SITE GROUP, LTD. HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS 04/16/2014
K914389 THE BINDING SITE, LTD. ALPHA-2 MACROGLOBULIN TEST RID KIT 12/20/1991


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