BOND ORACLE HER2 IHC SYSTEM
FDA premarket approval P090015/S004 · decided 2017-02-15
Approval details
- PMA number
- P090015
- Supplement
- S004
- 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
- 2017-02-02
- Decision date
- 2017-02-15
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- Transfer of several items of equipment from one testing laboratory to another laboratory within the same manufacture site. The equipment is used to complete the Quality Control testing of the BOND Oracle HER2 IHC System.
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