PMA P970018S035
- Device
- BD Totalys SlidePrep
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S035
- Product code
- MKQ
- Decision date
- 2018-01-12
- Classification
- Processor, Cervical Cytology Slide, Automated
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- Approval for labeling changes to the BD Totalys MultiProcessor and SlidePrep.
Current openFDA PMA Record#
- Device
- BD Totalys SlidePrep
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S035
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2018-01-12
- Decision code
- APPR
- Date received
- 2017-07-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for labeling changes to the BD Totalys MultiProcessor and SlidePrep.