PMA P970018S007
- Device
- PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S007
- Product code
- MKQ
- Decision date
- 2004-05-28
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- APPROVAL FOR MODIFIED LABELING OF THE PREPSTAIN SYSTEM FOR USE WITH AN ALTERNATE SPECIMEN COLLECTION DEVICE.
Current openFDA PMA Record#
- Device
- PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S007
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2004-05-28
- Decision code
- APPR
- Date received
- 2003-12-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFIED LABELING OF THE PREPSTAIN SYSTEM FOR USE WITH AN ALTERNATE SPECIMEN COLLECTION DEVICE.