PMA P970018S018
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S018
- Product code
- MKQ
- Decision date
- 2010-04-02
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIPATH IMAGING, INC., MEBANE, NORTH CAROLINA.
Current openFDA PMA Record#
- Device
- BD PREPSTAIN SYSTEM
- Applicant
- Bd Diagnostic Systems
- PMA number
- P970018
- Supplement
- S018
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2010-04-02
- Decision code
- APPR
- Date received
- 2009-09-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIPATH IMAGING, INC., MEBANE, NORTH CAROLINA.