FDA 510(k) Applications for Medical Device Product Code "DEB"
|
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 |