DEH · Class II · 21 CFR 866.5550

FDA Product Code DEH: Lambda, Antigen, Antiserum, Control

Leading manufacturers include Ventana Medical Systems, Inc., Dako Corp. and The Binding Site, Ltd..

53
Total
53
Cleared
406d
Avg days
1977
Since

FDA 510(k) Cleared Lambda, Antigen, Antiserum, Control Devices (Product Code DEH)

53 devices
1–24 of 53
Cleared May 08, 2018
VENTANA CD30 (Ber-H2) RxDx Assay
K172471
Ventana Medical Systems, Inc.
Medical Genetics · 266d
Cleared Apr 16, 2014
FREELITE HUMAN LAMBDA FREE KIT
K140396
The Binding Site Group , Ltd.
Immunology · 57d
Cleared Jan 30, 2004
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
K033811
The Binding Site, Ltd.
Immunology · 52d
Cleared Jul 15, 2003
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
K031016
The Binding Site, Ltd.
Immunology · 106d
Cleared Jan 21, 2003
FREELITE HUMAN LAMBDA FREE KIT
K023131
The Binding Site, Ltd.
Immunology · 134d
Cleared Apr 26, 2001
FREELITE LAMBDA FREE KIT
K010440
The Binding Site, Ltd.
Immunology · 72d
Cleared Apr 26, 2001
FREELITE KAPPA FREE KIT
K010441
The Binding Site, Ltd.
Immunology · 72d
Cleared Feb 01, 2001
LAMBDA IMMAGE FREELITE KIT
K003671
The Binding Site, Ltd.
Immunology · 65d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002563
The Binding Site, Ltd.
Immunology · 70d
Cleared Dec 12, 1997
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
K971905
Dako Corp.
Immunology · 203d
Cleared Nov 06, 1997
MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)
K965022
Dako Corp.
Immunology · 325d
Cleared Oct 20, 1997
VENTANA CD45 PRIMARY ANTIBODY
K940583
Ventana Medical Systems, Inc.
Immunology · 1350d
Cleared Sep 25, 1997
CHEMMATE LCA
K973393
Ventana Medical Systems, Inc.
Immunology · 86d
Cleared Apr 25, 1997
VENTANA ANTI-S100 PRIMARY ANTIBODY
K941514
Ventana Medical Systems, Inc.
Immunology · 1123d
Cleared Apr 22, 1997
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
K941170
Ventana Medical Systems, Inc.
Immunology · 1135d
Cleared Apr 21, 1997
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
K941707
Ventana Medical Systems, Inc.
Immunology · 1111d
Cleared Feb 14, 1997
VENTANA ANTI-CD4 PRIMARY ANTIBODY
K941604
Ventana Medical Systems, Inc.
Immunology · 1050d
Cleared Feb 14, 1997
VENTANA ANTI-CD8 PRIMARY ANTIBODY
K941784
Ventana Medical Systems, Inc.
Immunology · 1040d
Cleared Feb 10, 1997
ANTI-VIMENTIN PRIMARY ANTIBODY
K941397
Ventana Medical Systems, Inc.
Immunology · 1056d
Cleared Feb 10, 1997
VENTANNA ANTI-DESMIN PRIMARY ANTIBODY
K941516
Ventana Medical Systems, Inc.
Immunology · 1049d
Cleared Sep 10, 1996
VENTANA ANTI-CD5 PRIMARY ANTIBODY
K941782
Ventana Medical Systems, Inc.
Immunology · 883d
Cleared Jul 05, 1996
DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION
K951965
Dako Corp.
Immunology · 435d
Cleared May 30, 1996
VENTANNA ANTI-CD3 PRIMARY ANTIBODY
K941505
Ventana Medical Systems, Inc.
Immunology · 793d
Cleared Mar 22, 1996
KERATIN PRIMARY ANTIBODY
K935161
Ventana Medical Systems, Inc.
Immunology · 875d

About Product Code DEH - Regulatory Context