FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K031857 |
BAYER DIAGNOSTICS CORP. |
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY |
09/04/2003 |
K964766 |
BECKMAN INSTRUMENTS, INC. |
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) |
04/25/1997 |
K050596 |
BIOKIT S.A. |
QUANTIA A1-AT |
05/13/2005 |
K972640 |
BOEHRINGER MANNHEIM CORP. |
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY |
01/09/1998 |
K965100 |
CRESTAT DIAGNOSTICS, INC. |
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT |
07/14/1997 |
K063610 |
DADE BEHRING, INC. |
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH |
01/11/2007 |
K053072 |
DADE BEHRING, INC. |
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN |
03/28/2006 |
K993444 |
KAMIYA BIOMEDICAL CO. |
K-ASSAY ALPHA-1 AT |
11/24/1999 |
K052819 |
Ortho-Clinical Diagnostics, Inc. |
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III |
12/23/2005 |
K010978 |
ROCHDIAG |
TINA-QUANT ALPHA-1 ANTITRYPSIN |
05/18/2001 |
K123256 |
THE BINDING SITE GROUP, LTD. |
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS |
07/03/2013 |
K011663 |
THE BINDING SITE, LTD. |
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS |
07/30/2001 |
K973391 |
VENTANA MEDICAL SYSTEMS, INC. |
CHEMMATE KAPPA |
10/03/1997 |
K973390 |
VENTANA MEDICAL SYSTEMS, INC. |
CHEMMATE L26 (CD20) |
10/03/1997 |
K973392 |
VENTANA MEDICAL SYSTEMS, INC. |
CHEMMATE LAMBDA |
10/03/1997 |
K973389 |
VENTANA MEDICAL SYSTEMS, INC. |
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING |
10/03/1997 |