PMA P970018S033
- Device
- BD SUREPATH COLLECTION VIAL
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S033
- Product code
- MKQ
- Decision date
- 2016-12-02
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- Approval for a change to the labeling on the BD SurePath Collection Vial for use with the BD PrepStain system.
Current openFDA PMA Record#
- Device
- BD SUREPATH COLLECTION VIAL
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S033
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2016-12-02
- Decision code
- APPR
- Date received
- 2016-05-27
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change to the labeling on the BD SurePath Collection Vial for use with the BD PrepStain system.