PMA P950009S017
- Device
- BD FOCAL POINT SLIDE PROFILER
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S017
- Product code
- MNM
- Decision date
- 2014-02-26
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR REPLACEMENT OF THE CURRENT SCAN CONTROLLER BOARD (SCB) UTILIZED IN THE BD FOCALPOINT¿ SLIDE PROFILER WITH DIGITAL IMAGE SYSTEM CONFIGURATION.
Current openFDA PMA Record#
- Device
- BD FOCAL POINT SLIDE PROFILER
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S017
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2014-02-26
- Decision code
- APPR
- Date received
- 2013-12-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REPLACEMENT OF THE CURRENT SCAN CONTROLLER BOARD (SCB) UTILIZED IN THE BD FOCALPOINT¿ SLIDE PROFILER WITH DIGITAL IMAGE SYSTEM CONFIGURATION.