BD FocalPoint GS Imaging System
FDA premarket approval P950009/S025 · decided 2021-11-23
Approval details
- PMA number
- P950009
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BD FocalPoint GS Imaging System
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Applicant
- Bd Diagnostics
- Date received
- 2021-09-02
- Decision date
- 2021-11-23
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- MNM
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Durham, NC
- Statement
- Approval for use of alternate image capture and focus boards in new and refurbished BD FocalPoint Slide Profiler configurations.
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