PMA P980018S025
- Device
- HercepTest
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S025
- Product code
- MVC
- Decision date
- 2020-06-30
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- Changes to mixing process of antibody dilutions.
Current openFDA PMA Record#
- Device
- HercepTest
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S025
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2020-06-30
- Decision code
- OK30
- Date received
- 2020-06-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to mixing process of antibody dilutions.