PMA P090015S009
- Device
- Bond Oracle HER2 IHC System
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S009
- Product code
- MVC
- Decision date
- 2019-10-25
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- Add an additional Incoming Quality Control (IQC) test for a reagent.
Current openFDA PMA Record#
- Device
- Bond Oracle HER2 IHC System
- Applicant
- Leica Biosystems
- PMA number
- P090015
- Supplement
- S009
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2019-10-25
- Decision code
- OK30
- Date received
- 2019-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an additional Incoming Quality Control (IQC) test for a reagent.