PMA P950009S011
- Device
- BD FOCALPOINT SLIDE PROFILER
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S011
- Product code
- MNM
- Decision date
- 2010-01-08
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- NEW VENDOR OF A COMPONENT PROGRAMMED TO CONTROL DIFFERENT ASPECTS OF THE IMAGE PROCESSING.
Current openFDA PMA Record#
- Device
- BD FOCALPOINT SLIDE PROFILER
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S011
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2010-01-08
- Decision code
- OK30
- Date received
- 2009-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- NEW VENDOR OF A COMPONENT PROGRAMMED TO CONTROL DIFFERENT ASPECTS OF THE IMAGE PROCESSING.