PMA P970018S038
- Device
- BD PrepStain System
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S038
- Product code
- MKQ
- Decision date
- 2021-05-20
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- Approval for (i) a software update for the BD Totalys MultiProcessor and (ii) a revised hardware and software configuration for the BD Totalys SlidePrep.
Current openFDA PMA Record#
- Device
- BD PrepStain System
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S038
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2021-05-20
- Decision code
- APPR
- Date received
- 2021-02-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for (i) a software update for the BD Totalys MultiProcessor and (ii) a revised hardware and software configuration for the BD Totalys SlidePrep.