BOND ORACLE HER2 IHC SYSTEM
FDA premarket approval P090015/S002 · decided 2015-02-13
Approval details
- PMA number
- P090015
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BOND ORACLE HER2 IHC SYSTEM
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Leica Biosystems
- Date received
- 2014-11-28
- Decision date
- 2015-02-13
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR INTRODUCTION OF BOND VERSION 5.1 SOFTWARE FOR USE ONTHE BOND ORACLE HER2 IHC SYSTEM.
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