GENESEARCH BREAST LYMPH NODE (BLN) ASSAY
FDA premarket approval P060017/S004 · decided 2009-12-17
Approval details
- PMA number
- P060017
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GENESEARCH BREAST LYMPH NODE (BLN) ASSAY
- Generic name
- RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
- Applicant
- Janssen Diagnostics
- Date received
- 2009-11-19
- Decision date
- 2009-12-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OCB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Raritan, NJ
- 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.
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