PMA P980018S019
- Device
- HERCEP TEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S019
- Product code
- MVC
- Decision date
- 2015-05-21
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- MODIFY THE IN PROCESS QUALITY CONTROL (IPC) TEST TO VERIFY THE PERFORMANCE OF BULK REAGENTS (INTERMEDIATES) DAB+ BUFFERED SUBSTRATE AND DAB+ CHROMOGEN.
Current openFDA PMA Record#
- Device
- HERCEP TEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S019
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2015-05-21
- Decision code
- OK30
- Date received
- 2015-04-27
- Supplement type
- 30-Day Notice
- Approval order statement
- MODIFY THE IN PROCESS QUALITY CONTROL (IPC) TEST TO VERIFY THE PERFORMANCE OF BULK REAGENTS (INTERMEDIATES) DAB+ BUFFERED SUBSTRATE AND DAB+ CHROMOGEN.