BOND Oracle HER2 IHC System
FDA premarket approval P090015/S006 · decided 2019-01-23
Approval details
- PMA number
- P090015
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BOND Oracle HER2 IHC System
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Leica Biosystems
- Date received
- 2018-10-26
- Decision date
- 2019-01-23
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Approval for replacement of BOND-MAX Slide Staining Assembly (SSA) Printed Wiring Assembly (PWA) and BOND software update from version 5.1 to 6.0.
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