Home / Device Classification / LOJ

LOJ — Kit, Test,Alpha-Fetoprotein For Testicular Cancer Class II

FDA Device Classification

FDA product code LOJ covers "Kit, Test,Alpha-Fetoprotein For Testicular Cancer", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel. At least 17 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LOJ
Device Class
Class II
Regulation Number
866.6010
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220176roche diagnosticsElecsys AFPSeptember 15, 2022
K213626ortho clinical diagnosticsVITROS AFPJune 15, 2022
K090236siemens healthcare diagnosticsDIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454April 27, 2009
K081709olympus life science research europa gmbh (europa)OLYMPUS AFP - ALPHA-FETOPROTEINMarch 16, 2009
K080017biomerieuxVIDAS AFP ASSAYSeptember 26, 2008
K071597dade behringDIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA June 4, 2008
K023894tosoh medicsST AIA-PACK AFP ENZYME IMMUNOASSAYDecember 17, 2002
K020807bayer diagnosticsAFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMOctober 1, 2002
K020806bayerACS:180 & ADVIA CENTAUR AFP IMMUNOASSAYMarch 27, 2002
K990138diagnostic systems laboratoriesDSL ACTIVE AFP ELISA, MODEL DSL-10-8400June 21, 1999
K983031ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAYDecember 18, 1998
K983263diagnostic productsIMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2December 7, 1998
K981354beckman instrumentsACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211May 1, 1998
K981282roche diagnosticsELECSYS AFPMay 1, 1998
K973351boehringer mannheimELECSYS AFPNovember 21, 1997
K972462bayerAFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEMSeptember 22, 1997
K851891richard scott elliottTERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMSJuly 19, 1985

FDA data resources