- Device
- HERCEP TEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S004
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2005-07-13
- Decision code
- OK30
- Date received
- 2005-06-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE SUPPLIER OF THE REAGENT FOR IMMUNIZATION OF RABBITS AND SUBSEQUENT CHANGES IN MANUFACTURING PROCESS AND QUALITY CONTROL PROCEDURES.