PMA P950009S009
- Device
- BD FOCALPOINT SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S009
- Product code
- MNM
- Decision date
- 2009-07-24
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE IMAGE, CAPTURE AND FOCUS (ICF) CIRCUIT BOARD IN THE BD FOCALPOINT PROFILER.
Current openFDA PMA Record#
- Device
- BD FOCALPOINT SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S009
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2009-07-24
- Decision code
- APPR
- Date received
- 2009-03-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE IMAGE, CAPTURE AND FOCUS (ICF) CIRCUIT BOARD IN THE BD FOCALPOINT PROFILER.