Bond Oracle HER2 IHC System
FDA premarket approval P090015/S009 · decided 2019-10-25
Approval details
- PMA number
- P090015
- Supplement
- S009
- 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
- 2019-09-09
- Decision date
- 2019-10-25
- Days to decision
- 46 days
- Decision code
- OK30
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Add an additional Incoming Quality Control (IQC) test for a reagent.
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