PMA P980018S016
- Device
- HERCAP TEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S016
- Product code
- MVC
- Decision date
- 2013-02-22
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- APPROVAL FOR ADDITION OF KADCYLA¿ (ADO-TRASTUZUMAB EMTANSINE) IN THE LABELING OF HERCEP TEST ¿.
Current openFDA PMA Record#
- Device
- HERCAP TEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S016
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2013-02-22
- Decision code
- APPR
- Date received
- 2012-08-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITION OF KADCYLA¿ (ADO-TRASTUZUMAB EMTANSINE) IN THE LABELING OF HERCEP TEST ¿.