PMA P090015S014
- Device
- BOND Oracle HER2 IHC System
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S014
- Product code
- MVC
- Decision date
- 2026-06-04
- Classification
- Pathology
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- a manufacturing QC change
Current openFDA PMA Record#
- Device
- BOND Oracle HER2 IHC System
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S014
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2026-06-04
- Decision code
- OK30
- Date received
- 2026-05-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing QC change