PMA P980018S018
- Device
- HERCEPTEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S018
- Product code
- MVC
- Decision date
- 2013-11-26
- Classification
- System, Test, Her-2/neu, Ihc
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Approval order statement
- APPROVAL FOR LABELING CHANGES MADE TO ENHANCE SAFETY OF HERCEPTEST. WHEN USED FOR GASTRIC AND GASTROESOPHAGEAL CANCER INDICATIONS.
Current openFDA PMA Record#
- Device
- HERCEPTEST
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- PMA number
- P980018
- Supplement
- S018
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2013-11-26
- Decision code
- APPR
- Date received
- 2013-11-21
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR LABELING CHANGES MADE TO ENHANCE SAFETY OF HERCEPTEST. WHEN USED FOR GASTRIC AND GASTROESOPHAGEAL CANCER INDICATIONS.