FDA 510(k) Applications for Medical Device Product Code "DEH"
(Lambda, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K842328 BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN 08/03/1984
K902485 BECKMAN INSTRUMENTS, INC. BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS) 06/21/1990
K936111 BIOTEK SOLUTIONS, INC. CHEMMATE SPECIAL STAIN LCA-CD45 02/27/1996
K950148 BIOTEK SOLUTIONS, INC. CHEMMATE(TM) CD43 07/02/1996
K950151 BIOTEK SOLUTIONS, INC. CHEMMATE(TM) L26 (CD20) 10/04/1995
K950149 BIOTEK SOLUTIONS, INC. CHEMMATE(TM) LAMBDA 12/06/1995
K951965 DAKO CORP. DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION 07/05/1996
K971905 DAKO CORP. DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING 12/12/1997
K924726 DAKO CORP. DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI 06/13/1994
K932136 DAKO CORP. DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45) 06/13/1994
K924804 DAKO CORP. DAKO MOUSE ANTI-HUMAN T-CELL 11/21/1994
K931192 DAKO CORP. DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY 04/20/1995
K812662 DAKO CORP. IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA 09/29/1981
K965022 DAKO CORP. MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) 11/06/1997
K896918 DAKO CORP. MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT 08/27/1990
K791283 DIAGNOSTICA, INC. ANTI-HUMAN LAMBDA SERUM 11/27/1979
K771768 G.D. SEARLE AND CO. GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM 10/07/1977
K832270 GELCO DIAGNOSTICS, INC. GOAT ANTI-HUMAN LAMBA 10/31/1983
K832261 GELCO DIAGNOSTICS, INC. GOAT ANTI-HUMAN LAMBA AFFINITY 10/28/1983
K781220 ICL SCIENTIFIC ANTI-HUMAN LAMBDA SERUM 07/27/1978
K781025 ICL SCIENTIFIC LAMBDA SERUM (FREE) ANTI-HUMAN 07/27/1978
K875165 KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK 01/22/1988
K855007 KALLESTAD LABORATORIES, INC. QUANTIMETRIC PLUS LAMBDA REAGENT KIT 02/26/1986
K855013 KALLESTAD LABORATORIES, INC. QUANTIMETRIC PLUS SUPPORT PACK 02/26/1986
K841864 KALLESTAD LABORATORIES, INC. QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT 07/11/1984
K852999 KALLESTAD LABORATORIES, INC. QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT 10/21/1985
K791115 PROTOS LABORATORIES GOAR ANTI-HUMAN LAMBODA CHAIN 08/03/1979
K083601 SENTINEL CH. SpA LAMBDA LIGHT CHAINS 06/22/2009
K140396 THE BINDING SITE GROUP, LTD. FREELITE HUMAN LAMBDA FREE KIT 04/16/2014
K031016 THE BINDING SITE, LTD. FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II 07/15/2003
K033811 THE BINDING SITE, LTD. FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER 01/30/2004
K023131 THE BINDING SITE, LTD. FREELITE HUMAN LAMBDA FREE KIT 01/21/2003
K010441 THE BINDING SITE, LTD. FREELITE KAPPA FREE KIT 04/26/2001
K010440 THE BINDING SITE, LTD. FREELITE LAMBDA FREE KIT 04/26/2001
K003671 THE BINDING SITE, LTD. LAMBDA IMMAGE FREELITE KIT 02/01/2001
K002563 THE BINDING SITE, LTD. SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT 10/26/2000
K941173 VENTANA MEDICAL SYSTEMS, INC. ANTI-KERATIN-HMW PRIMARY ANTI-BODY 03/22/1996
K941707 VENTANA MEDICAL SYSTEMS, INC. ANTI-MUSCLE ACTIN PRIMARY ANTIBODY 04/21/1997
K941397 VENTANA MEDICAL SYSTEMS, INC. ANTI-VIMENTIN PRIMARY ANTIBODY 02/10/1997
K973393 VENTANA MEDICAL SYSTEMS, INC. CHEMMATE LCA 09/25/1997
K940331 VENTANA MEDICAL SYSTEMS, INC. KERATIN PRIMARY ANTIBODY 02/26/1996
K935161 VENTANA MEDICAL SYSTEMS, INC. KERATIN PRIMARY ANTIBODY 03/22/1996
K932326 VENTANA MEDICAL SYSTEMS, INC. PSA ANTIBODY KIT 08/06/1993
K941604 VENTANA MEDICAL SYSTEMS, INC. VENTANA ANTI-CD4 PRIMARY ANTIBODY 02/14/1997
K941782 VENTANA MEDICAL SYSTEMS, INC. VENTANA ANTI-CD5 PRIMARY ANTIBODY 09/10/1996
K941784 VENTANA MEDICAL SYSTEMS, INC. VENTANA ANTI-CD8 PRIMARY ANTIBODY 02/14/1997
K941170 VENTANA MEDICAL SYSTEMS, INC. VENTANA ANTI-MELANOMA PRIMARY ANTIBODY 04/22/1997
K941514 VENTANA MEDICAL SYSTEMS, INC. VENTANA ANTI-S100 PRIMARY ANTIBODY 04/25/1997
K940424 VENTANA MEDICAL SYSTEMS, INC. VENTANA BLUE DETECTION KIT 11/06/1995
K172471 Ventana Medical Systems, Inc. VENTANA CD30 (Ber-H2) RxDx Assay 05/08/2018
K940583 VENTANA MEDICAL SYSTEMS, INC. VENTANA CD45 PRIMARY ANTIBODY 10/20/1997
K941505 VENTANA MEDICAL SYSTEMS, INC. VENTANNA ANTI-CD3 PRIMARY ANTIBODY 05/30/1996
K941516 VENTANA MEDICAL SYSTEMS, INC. VENTANNA ANTI-DESMIN PRIMARY ANTIBODY 02/10/1997


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