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510(k) K031393

Device
BAYER ADVIA CENTAUR CA 19-9 ASSAY
Applicant
BAYER HEALTHCARE, LLC
510(k) number
K031393
Product code
NIG  
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-24
Date received
2003-05-02
Regulation
866.6010
Classification name
System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

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 NIG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical Diagnostics2023-08-09
K200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc.2020-05-14
K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.2019-10-22
K100375DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604Siemens Healthcare Diagnostics, Inc.2011-04-06
K052889VITROS CA 19-9Fujirebio Diagnostics,Inc.2005-12-20
K052000ARCHITECT CA 19-9XR ASSAYFujirebio Diagnostics,Inc.2005-10-25
K033038GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688Beckman Coulter, Inc.2003-12-29
K023239AIA-PACK CA 19-9Tosoh Corp.2002-12-23
K023240ST AIA-PACK CA 19-9Tosoh Corp.2002-12-23
K020566FUJIREBIO DIAGNOSTICS CA 19-9 RIAFujirebio Diagnostics,Inc.2002-05-09

Legacy Summary#

summary

FDA Review#

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