LEICA BOND ORACLE HER2 IHC SYSTEM
FDA premarket approval P090015/S003 · decided 2015-05-20
Approval details
- PMA number
- P090015
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LEICA BOND ORACLE HER2 IHC SYSTEM
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Leica Biosystems
- Date received
- 2015-04-20
- Decision date
- 2015-05-20
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR LABELLING CHANGES.
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