PMA P950009S025
- Device
- BD FocalPoint GS Imaging System
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S025
- Product code
- MNM
- Decision date
- 2021-11-23
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- Approval for use of alternate image capture and focus boards in new and refurbished BD FocalPoint Slide Profiler configurations.
Current openFDA PMA Record#
- Device
- BD FocalPoint GS Imaging System
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S025
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2021-11-23
- Decision code
- APPR
- Date received
- 2021-09-02
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for use of alternate image capture and focus boards in new and refurbished BD FocalPoint Slide Profiler configurations.