PMA P970018S025
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S025
- Product code
- MKQ
- Decision date
- 2012-11-08
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- APPROVAL FOR A SUPPLIER CHANGE TO THE RAW MICROSOPE SLIDE, A CRITICAL COMPONENT IN THE DEVICE.
Current openFDA PMA Record#
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S025
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2012-11-08
- Decision code
- APPR
- Date received
- 2012-05-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A SUPPLIER CHANGE TO THE RAW MICROSOPE SLIDE, A CRITICAL COMPONENT IN THE DEVICE.