PMA P950009S018
- Device
- BD FOCALPOINT SLIDE PROFILER
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S018
- Product code
- MNM
- Decision date
- 2016-02-12
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- Approval for the BD FocalPoint™ Slide Profiler with slides prepared by the BD Totalys™ SlidePrep.
Current openFDA PMA Record#
- Device
- BD FOCALPOINT SLIDE PROFILER
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S018
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2016-02-12
- Decision code
- APPR
- Date received
- 2014-11-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the BD FocalPoint™ Slide Profiler with slides prepared by the BD Totalys™ SlidePrep.