PMA P980018S011
- Device
- HERCEPTEST KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S011
- Product code
- MVC
- Decision date
- 2011-02-17
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- APPROVAL OF THE DAKOLINK V3.1.0. SOFTWARE FOR HERCEPTEST KIT.
Current openFDA PMA Record#
- Device
- HERCEPTEST KIT
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S011
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2011-02-17
- Decision code
- APPR
- Date received
- 2010-09-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF THE DAKOLINK V3.1.0. SOFTWARE FOR HERCEPTEST KIT.