HERCEP TEST
FDA premarket approval P980018/S006 · decided 2010-02-25
Approval details
- PMA number
- P980018
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HERCEP TEST
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2008-05-28
- Decision date
- 2010-02-25
- Days to decision
- 638 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL TO MARKET THE HERCEPTEST KIT FOR AUTOMATED LINK PLATFORMS AND THE CHANGES INVOLVED IN THE ASSAY PROCEDURE TO USE THE NEW INSTRUMENT, CHANGE IN THE QC PROCEDURE WITH REFERENCE TO CHROMOGEN, CHANGES IN THE CRITERIA REGARDING THE CONTROL TISSUE DURING QC AND CHANGES IN THE SPECIMEN PREPARATION.
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