PMA P980018S009
- Device
- HERCEPTEST KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S009
- Product code
- MVC
- Decision date
- 2010-10-07
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- APPROVAL FOR A CHANGE IN THE FORMULATION OF THE HERCEPTEST EPITOPE RETRIEVAL SOLUTION.
Current openFDA PMA Record#
- Device
- HERCEPTEST KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S009
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2010-10-07
- Decision code
- APPR
- Date received
- 2010-02-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE FORMULATION OF THE HERCEPTEST EPITOPE RETRIEVAL SOLUTION.