PMA P090015S002
- Device
- BOND ORACLE HER2 IHC SYSTEM
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S002
- Product code
- MVC
- Decision date
- 2015-02-13
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- APPROVAL FOR INTRODUCTION OF BOND VERSION 5.1 SOFTWARE FOR USE ONTHE BOND ORACLE HER2 IHC SYSTEM.
Current openFDA PMA Record#
- Device
- BOND ORACLE HER2 IHC SYSTEM
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S002
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2015-02-13
- Decision code
- APPR
- Date received
- 2014-11-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR INTRODUCTION OF BOND VERSION 5.1 SOFTWARE FOR USE ONTHE BOND ORACLE HER2 IHC SYSTEM.