DEB · Class II · 21 CFR 866.5620

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

Leading manufacturers include Beckman Instruments, Inc., Dade Behring, Inc. and Kallestad Laboratories, 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 Apr 16, 2014
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS
K140664
The Binding Site Group , Ltd.
Immunology · 29d
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 Dec 20, 1991
ALPHA-2 MACROGLOBULIN TEST RID KIT
K914389
The Binding Site, Ltd.
Immunology · 80d
Cleared Dec 01, 1989
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
K896483
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 18d
Cleared Nov 27, 1985
72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2
K850683
Kent Laboratories, Inc.
Immunology · 279d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO
K812493
Dako Corp.
Immunology · 23d
Cleared Aug 16, 1979
HUMAN ALPHA2 MACROGLOBULIN
K791340
Beckman Instruments, Inc.
Immunology · 31d
Cleared Dec 22, 1977
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY
K772246
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Oct 04, 1977
LAS-R TM
K771780
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 11d

About Product Code DEB - Regulatory Context