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510(k) K024017

Device
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
Applicant
BAYER CORP.
510(k) number
K024017
Product code
NCW  
Decision
Substantially Equivalent (SESE)
Decision date
2003-01-30
Date received
2002-12-04
Regulation
866.6010
Classification name
System, Test, Her-2/neu, Monitoring
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 NCW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992228BAYER IMMUNO 1 HER-2/NEU ASSAYBayer Corp.2000-09-29
K994112MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)Oncogene Science, Inc.2000-09-29

Legacy Summary#

summary

FDA Review#

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