GENESEARCH BREAST LYMPH NODE
FDA premarket approval P060017/S001 · decided 2007-10-23
Approval details
- PMA number
- P060017
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- GENESEARCH BREAST LYMPH NODE
- Generic name
- RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
- Applicant
- Janssen Diagnostics
- Date received
- 2007-08-15
- Decision date
- 2007-10-23
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- OCB
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Raritan, NJ
- Statement
- APPROVAL FOR THE POST-APPROVAL STUDY.
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