PMA P950009S010
- Device
- BD FOCALPOINT GS IMAGING SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S010
- Product code
- MNM
- Decision date
- 2010-03-15
- Classification
- Reader, Cervical Cytology Slide, Automated
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIPATH IMAGING, INC. IN MELBANE, NORTH CAROLINA.
Current openFDA PMA Record#
- Device
- BD FOCALPOINT GS IMAGING SYSTEM
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S010
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2010-03-15
- Decision code
- APPR
- Date received
- 2009-06-25
- 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. IN MELBANE, NORTH CAROLINA.