PMA P060017S004

Device: GENESEARCH BREAST LYMPH NODE (BLN) ASSAY
Applicant: Janssen Diagnostics
PMA number: P060017
Supplement: S004
Product code: OCB
Decision date: 2009-12-17
Generic name: RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
Approval order statement: EXTENSION OF SHELF-LIFE OF PLASMID DNA RAW MATERIAL USED IN THE MANUFACTURE OF THE EXTERNAL POSITIVE AND EXTERNAL NEGATIVE CONTROLS OF THE DEVICE.

Current openFDA PMA Record#

Device: GENESEARCH BREAST LYMPH NODE (BLN) ASSAY
Applicant: Janssen Diagnostics
PMA number: P060017
Supplement: S004
Product code: OCB
Generic name: RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
Decision date: 2009-12-17
Decision code: OK30
Date received: 2009-11-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: EXTENSION OF SHELF-LIFE OF PLASMID DNA RAW MATERIAL USED IN THE MANUFACTURE OF THE EXTERNAL POSITIVE AND EXTERNAL NEGATIVE CONTROLS OF THE DEVICE.