PMA P970018S027
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S027
- Product code
- MKQ
- Decision date
- 2013-10-16
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE BD PREPSTAIN¿ SYSTEM.
Current openFDA PMA Record#
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S027
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2013-10-16
- Decision code
- APPR
- Date received
- 2013-09-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE BD PREPSTAIN¿ SYSTEM.