PMA P970018S037
- Device
- BD PrepStain System
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S037
- Product code
- MKQ
- Decision date
- 2021-02-16
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- Change in manufacturing process for BD SurePath Precoat Slides.
Current openFDA PMA Record#
- Device
- BD PrepStain System
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S037
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2021-02-16
- Decision code
- OK30
- Date received
- 2021-01-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in manufacturing process for BD SurePath Precoat Slides.