HERCEPTEST
FDA premarket approval P980018/S003 · decided 2005-12-30
Approval details
- PMA number
- P980018
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2004-11-10
- Decision date
- 2005-12-30
- Days to decision
- 415 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT DAKO DENMARK A/S, GLOSTRUP, DENMARK.
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