PMA P950009S022
- Device
- BD FocalPoint GS Imaging System
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S022
- Product code
- MNM
- Decision date
- 2019-09-05
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- Approval for hardware and associated software modifications necessary to achieve compliance to the European Union RoHS Directive.
Current openFDA PMA Record#
- Device
- BD FocalPoint GS Imaging System
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S022
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2019-09-05
- Decision code
- APPR
- Date received
- 2019-06-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for hardware and associated software modifications necessary to achieve compliance to the European Union RoHS Directive.