FDA 510(k) Applications for Medical Device Product Code "DEM"
(Alpha-1-Antitrypsin, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K850587 APPLICATIONS LAB SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN 03/14/1985
K890415 ATLANTIC ANTIBODIES SPQ(TM) ANTIBODY REAGENT SET II FOR AAT 02/17/1989
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
K760034 GAMMA BIOLOGICALS, INC. TEST, STREP, LATEX SLIDE 08/11/1976
K772080 GELMAN INSTRUMENT CO. RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT 02/03/1978
K760916 HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES LAS-R HUMAN ALPHA, ANTITRYPSIN TEST 11/16/1976
K781408 ICL SCIENTIFIC RID SYSTEM-(ACP) TEST 08/21/1978
K920005 INSTRUMENTATION LABORATORY CO. IL TEST ALPHA-1-ANTITRYPSIN (AAT) 07/29/1992
K801669 J.T. BAKER CHEMICAL CO. J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO 09/16/1980
K875283 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM2/QM300 CONTROL B PACK 02/10/1988
K875281 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK 02/10/1988
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
K791605 PROTOS LABORATORIES GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN 09/04/1979
K010978 ROCHDIAG TINA-QUANT ALPHA-1 ANTITRYPSIN 05/18/2001
K882446 TECHNICON INSTRUMENTS CORP. ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM 07/08/1988
K123256 THE BINDING SITE GROUP, LTD. HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS 07/03/2013
K913666 THE BINDING SITE, LTD. ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT 12/09/1991
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
K931979 VENTANA MEDICAL SYSTEMS, INC. VENTANA NEGATIVE CONTROL REAGENT 03/30/1994


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact