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DEH — Lambda, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
DEH
Device Class
Class II
Regulation Number
866.5550
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K172471ventana medical systemsVENTANA CD30 (Ber-H2) RxDx AssayMay 8, 2018
K140396binding site groupFREELITE HUMAN LAMBDA FREE KITApril 16, 2014
K083601sentinel chLAMBDA LIGHT CHAINSJune 22, 2009
K033811binding siteFREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERJanuary 30, 2004
K031016binding siteFREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETEJuly 15, 2003
K023131binding siteFREELITE HUMAN LAMBDA FREE KITJanuary 21, 2003
K010440binding siteFREELITE LAMBDA FREE KITApril 26, 2001
K010441binding siteFREELITE KAPPA FREE KITApril 26, 2001
K003671binding siteLAMBDA IMMAGE FREELITE KITFebruary 1, 2001
K002563binding siteSHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KITOctober 26, 2000
K971905dakoDAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONDecember 12, 1997
K965022dakoMONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMANovember 6, 1997
K940583ventana medical systemsVENTANA CD45 PRIMARY ANTIBODYOctober 20, 1997
K973393ventana medical systemsCHEMMATE LCASeptember 25, 1997
K941514ventana medical systemsVENTANA ANTI-S100 PRIMARY ANTIBODYApril 25, 1997
K941170ventana medical systemsVENTANA ANTI-MELANOMA PRIMARY ANTIBODYApril 22, 1997
K941707ventana medical systemsANTI-MUSCLE ACTIN PRIMARY ANTIBODYApril 21, 1997
K941784ventana medical systemsVENTANA ANTI-CD8 PRIMARY ANTIBODYFebruary 14, 1997
K941604ventana medical systemsVENTANA ANTI-CD4 PRIMARY ANTIBODYFebruary 14, 1997
K941516ventana medical systemsVENTANNA ANTI-DESMIN PRIMARY ANTIBODYFebruary 10, 1997