PMA P950009S015

Device
BD FOCALPOINT SLIDE PROFILER
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S015
Product code
MNM
Decision date
2013-09-13
Classification
Reader, Cervical Cytology Slide, Automated
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Approval order statement
APPROVAL FOR THE BD FOCALPOINT SLIDE PROFILER WITH THE NEW DIGITAL PRIMARYCAMERA.

Current openFDA PMA Record#

Device
BD FOCALPOINT SLIDE PROFILER
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S015
Product code
MNM
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Decision date
2013-09-13
Decision code
APPR
Date received
2012-03-28
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE BD FOCALPOINT SLIDE PROFILER WITH THE NEW DIGITAL PRIMARYCAMERA.