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
K974564 BECKMAN INSTRUMENTS, INC. IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT 02/17/1998
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
K140664 THE BINDING SITE GROUP, LTD. HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS 04/16/2014


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact