DAKO HERCEPTEST
FDA premarket approval P980018/S021 · decided 2016-05-27
Approval details
- PMA number
- P980018
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DAKO HERCEPTEST
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2016-02-29
- Decision date
- 2016-05-27
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- Approval for addition of Dako PT Link programmable water bath, PT200 for pre-treatment of tissue sections when using HercepTest for Automated Link Platforms.
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