HERCEPTEST KIT
FDA premarket approval P980018/S009 · decided 2010-10-07
Approval details
- PMA number
- P980018
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HERCEPTEST KIT
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2010-02-25
- Decision date
- 2010-10-07
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR A CHANGE IN THE FORMULATION OF THE HERCEPTEST EPITOPE RETRIEVAL SOLUTION.
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