HERCEPTEST
FDA premarket approval P980018/S018 · decided 2013-11-26
Approval details
- PMA number
- P980018
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- Trade name
- HERCEPTEST
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2013-11-21
- Decision date
- 2013-11-26
- Days to decision
- 5 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR LABELING CHANGES MADE TO ENHANCE SAFETY OF HERCEPTEST. WHEN USED FOR GASTRIC AND GASTROESOPHAGEAL CANCER INDICATIONS.
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