HERCEPTEST KIT
FDA premarket approval P980018/S011 · decided 2011-02-17
Approval details
- PMA number
- P980018
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- 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
- 2010-09-09
- Decision date
- 2011-02-17
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL OF THE DAKOLINK V3.1.0. SOFTWARE FOR HERCEPTEST KIT.
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