BOND Oracle HER2 IHC System
FDA premarket approval P090015/S012 · decided 2020-10-20
Approval details
- PMA number
- P090015
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BOND Oracle HER2 IHC System
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Leica Biosystems
- Date received
- 2020-08-28
- Decision date
- 2020-10-20
- Days to decision
- 53 days
- Decision code
- OK30
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Addition of a reagent supplier.
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