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510(k) K020807

Device
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
Applicant
Bayer Diagnostics Corp.
510(k) number
K020807
Product code
LOJ
Decision
Substantially Equivalent (SESE)
Decision date
2002-10-01
Date received
2002-03-12
Regulation
866.6010
Classification name
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
KENNETH T EDDS
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LOJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220176Elecsys AFPRoche Diagnostics2022-09-15
K213626VITROS AFPOrtho Clinical Diagnostics2022-06-15
K090236DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454Siemens Healthcare Diagnostics2009-04-27
K081709OLYMPUS AFP - ALPHA-FETOPROTEINOlympus Life Science Research Europa GmbH (Europa)2009-03-16
K080017VIDAS AFP ASSAYbioMerieux, Inc.2008-09-26
K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600Dade Behring, Inc.2008-06-04
K023894ST AIA-PACK AFP ENZYME IMMUNOASSAYTosoh Medics, Inc.2002-12-17
K020806ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAYBayer Corp.2002-03-27
K990138DSL ACTIVE AFP ELISA, MODEL DSL-10-8400Diagnostic Systems Laboratories, Inc.1999-06-21
K983031VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAYOrtho-Clinical Diagnostics, Inc.1998-12-18
K983263IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2Diagnostic Products Corp.1998-12-07
K981282ELECSYS AFPRoche Diagnostics GmbH1998-05-01
K981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211Beckman Instruments, Inc.1998-05-01
K973351ELECSYS AFPBoehringer Mannheim Corp.1997-11-21
K972462AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEMBayer Corp.1997-09-22