PMA P970018S004
- Device
- PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S004
- Product code
- MKQ
- Decision date
- 2002-10-01
- Classification
- Processor, Cervical Cytology Slide, Automated
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- APPROVAL FOR STOPPING THE POST-APPROVAL REPORTING REQUIREMENT FOR A DIRECT-TO-VIAL STUDY FOR THE PREPSTAIN SYSTEM.
Current openFDA PMA Record#
- Device
- PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S004
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2002-10-01
- Decision code
- APPR
- Date received
- 2002-07-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR STOPPING THE POST-APPROVAL REPORTING REQUIREMENT FOR A DIRECT-TO-VIAL STUDY FOR THE PREPSTAIN SYSTEM.