PMA P980018
- Device
- HercepTest™
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S025
- Product code
- MVC
- Decision date
- 2026-09-21
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- approval for a supplier's change to the manufacturing sight for a device component
Current openFDA PMA Record#
- Device
- HercepTest™
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S027
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2026-09-21
- Decision code
- OK30
- Date received
- 2026-07-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a supplier's change to the manufacturing sight for a device component