PMA P980018S003
- Device
- HERCEPTEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S003
- Product code
- MVC
- Decision date
- 2005-12-30
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARK A/S, GLOSTRUP, DENMARK.
Current openFDA PMA Record#
- Device
- HERCEPTEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S003
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2005-12-30
- Decision code
- APPR
- Date received
- 2004-11-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARK A/S, GLOSTRUP, DENMARK.