- Device
- DAKO HERCEPTEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S021
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2016-05-27
- Decision code
- APPR
- Date received
- 2016-02-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for addition of Dako PT Link programmable water bath, PT200 for pre-treatment of tissue sections when using HercepTest for Automated Link Platforms.