HERCEPTEST
FDA premarket approval P980018/S013 · decided 2011-04-18
Approval details
- PMA number
- P980018
- Supplement
- S013
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HERCEPTEST
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2011-04-06
- Decision date
- 2011-04-18
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- APPROVAL FOR LABELING CHANGES THAT ADD PRECAUTION AND AN INSTRUCTION THAT IS INTENDED TO ENHANCE THE SAFE USE OF HERCEPTEST.
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