HERCEPTEST
FDA premarket approval P980018/S012 · decided 2011-02-11
Approval details
- PMA number
- P980018
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HERCEPTEST
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2011-01-24
- Decision date
- 2011-02-11
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- AUTOMATED FILING OF DAB CHROMOGEN FOR HERCEPTEST AS THE PRIMARY FILING PROCESS.
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