DEM · Class II · 21 CFR 866.5130

FDA Product Code DEM: Alpha-1-antitrypsin, Antigen, Antiserum, Control

Leading manufacturers include Dade Behring, Inc., Instrumentation Laboratory CO and Beckman Instruments, Inc..

30
Total
30
Cleared
93d
Avg days
1976
Since

FDA 510(k) Cleared Alpha-1-antitrypsin, Antigen, Antiserum, Control Devices (Product Code DEM)

30 devices
1–24 of 30
Cleared Jan 11, 2007
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K063610
Dade Behring, Inc.
Immunology · 38d
Cleared Mar 28, 2006
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
K053072
Dade Behring, Inc.
Immunology · 147d
Cleared Jan 09, 1998
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
K972640
Boehringer Mannheim Corp.
Immunology · 178d
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766
Beckman Instruments, Inc.
Immunology · 149d
Cleared Jul 29, 1992
IL TEST ALPHA-1-ANTITRYPSIN (AAT)
K920005
Instrumentation Laboratory CO
Immunology · 209d

About Product Code DEM - Regulatory Context