PMA P970018S015
- Device
- PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S015
- Product code
- MKQ
- Decision date
- 2009-07-24
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- APPROVAL FOR THE CHANGES MADE TO THE PREPSTAIN SOFTWARE PROGRAM IN RESPONSE TO RECALL Z-1090-2009.
Current openFDA PMA Record#
- Device
- PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S015
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2009-07-24
- Decision code
- APPR
- Date received
- 2009-05-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE CHANGES MADE TO THE PREPSTAIN SOFTWARE PROGRAM IN RESPONSE TO RECALL Z-1090-2009.