DEB · Class II · 21 CFR 866.5620

FDA Product Code DEB: Alpha-2-macroglobulin, Antigen, Antiserum, Control

Leading manufacturers include Dade Behring, Inc. and Beckman Instruments, Inc..

13
Total
13
Cleared
66d
Avg days
1977
Since

FDA 510(k) Cleared Alpha-2-macroglobulin, Antigen, Antiserum, Control Devices (Product Code DEB)

13 devices
1–13 of 13
Cleared Jul 21, 2008
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
K081249
Dade Behring, Inc.
Immunology · 80d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
K053073
Dade Behring, Inc.
Immunology · 147d
Cleared Feb 17, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
K974564
Beckman Instruments, Inc.
Immunology · 74d
Cleared Aug 16, 1979
HUMAN ALPHA2 MACROGLOBULIN
K791340
Beckman Instruments, Inc.
Immunology · 31d

About Product Code DEB - Regulatory Context