HERCEP TEST
FDA premarket approval P980018/S019 · decided 2015-05-21
Approval details
- PMA number
- P980018
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Trade name
- HERCEP TEST
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Agilent Technologies Singapore (International) Pte , Ltd.
- Date received
- 2015-04-27
- Decision date
- 2015-05-21
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Singapore
- Statement
- MODIFY THE IN PROCESS QUALITY CONTROL (IPC) TEST TO VERIFY THE PERFORMANCE OF BULK REAGENTS (INTERMEDIATES) DAB+ BUFFERED SUBSTRATE AND DAB+ CHROMOGEN.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.