PMA P060017S003

Device: GENESEARCH BREAST LYMPH NODE ASSAY
Applicant: Janssen Diagnostics
PMA number: P060017
Supplement: S003
Product code: OCB
Decision date: 2009-07-09
Generic name: RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
Approval order statement: APPROVAL FOR: 1) A MANUFACTURING SITE LOCATED AT VERIDEX, LLC IN WARREN, NEW JERSEY; 2) THE ADDITION OF A SECOND EXISTING SITE; AND 3) A CHANGE IN RAW MATERIAL SPECIFICATIONS.

Current openFDA PMA Record#

Device: GENESEARCH BREAST LYMPH NODE ASSAY
Applicant: Janssen Diagnostics
PMA number: P060017
Supplement: S003
Product code: OCB
Generic name: RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
Decision date: 2009-07-09
Decision code: APPR
Date received: 2009-03-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR: 1) A MANUFACTURING SITE LOCATED AT VERIDEX, LLC IN WARREN, NEW JERSEY; 2) THE ADDITION OF A SECOND EXISTING SITE; AND 3) A CHANGE IN RAW MATERIAL SPECIFICATIONS.