PMA P090015S003
- Device
- LEICA BOND ORACLE HER2 IHC SYSTEM
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S003
- Product code
- MVC
- Decision date
- 2015-05-20
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- APPROVAL FOR LABELLING CHANGES.
Current openFDA PMA Record#
- Device
- LEICA BOND ORACLE HER2 IHC SYSTEM
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S003
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2015-05-20
- Decision code
- APPR
- Date received
- 2015-04-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELLING CHANGES.