PMA P090015S010
- Device
- BOND ORACLE HER2 IHC SYSTEM
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S010
- Product code
- MVC
- Decision date
- 2020-01-02
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- Addition of an item to the list of 'equipment required but not supplied.
Current openFDA PMA Record#
- Device
- BOND ORACLE HER2 IHC SYSTEM
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S010
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2020-01-02
- Decision code
- OK30
- Date received
- 2019-12-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an item to the list of 'equipment required but not supplied.