- Device
- BD Totalys MultiProcessor
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S039
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2021-12-21
- Decision code
- APPR
- Date received
- 2021-09-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the minor design changes to the BD Totalys MultiProcessor electronic hardware components, process deck cover, and software modifications to support changes in reagent/waste capacity, operating system, batch types, and service tools.