PMA P090015S006
- Device
- BOND Oracle HER2 IHC System
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S006
- Product code
- MVC
- Decision date
- 2019-01-23
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- Approval for replacement of BOND-MAX Slide Staining Assembly (SSA) Printed Wiring Assembly (PWA) and BOND software update from version 5.1 to 6.0.
Current openFDA PMA Record#
- Device
- BOND Oracle HER2 IHC System
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S006
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2019-01-23
- Decision code
- APPR
- Date received
- 2018-10-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for replacement of BOND-MAX Slide Staining Assembly (SSA) Printed Wiring Assembly (PWA) and BOND software update from version 5.1 to 6.0.