PMA P950009S013
- Device
- BD FOCALPOINT SLIDE PROFILER
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S013
- Product code
- MNM
- Decision date
- 2011-11-10
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE BD FOCALPOINT SLIDE PROFILER FROM THE CURRENT PRODUCTION VERSION APPS 3.4.1A TO APPS 3.5.0.
Current openFDA PMA Record#
- Device
- BD FOCALPOINT SLIDE PROFILER
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S013
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2011-11-10
- Decision code
- APPR
- Date received
- 2011-09-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE BD FOCALPOINT SLIDE PROFILER FROM THE CURRENT PRODUCTION VERSION APPS 3.4.1A TO APPS 3.5.0.