PMA P970018S032
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S032
- Product code
- MKQ
- Decision date
- 2016-02-12
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- Approval for the BD Totalys™ MultiProcessor, a new cell enrichment system, and the BD SurePath™ collection vial.
Current openFDA PMA Record#
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S032
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2016-02-12
- Decision code
- APPR
- Date received
- 2015-03-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the BD Totalys™ MultiProcessor, a new cell enrichment system, and the BD SurePath™ collection vial.