PMA P950009S014

Device
BD FOCALPOINT SLIDE PROFILER
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S014
Product code
MNM
Decision date
2012-03-09
Classification
Reader, Cervical Cytology Slide, Automated
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Approval order statement
APPROVAL FOR UPDATING THE FIELD OF VIEW (FOV) BOARD FROM VERSION 2 TO VERSION 3.

Current openFDA PMA Record#

Device
BD FOCALPOINT SLIDE PROFILER
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S014
Product code
MNM
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Decision date
2012-03-09
Decision code
APPR
Date received
2012-01-17
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR UPDATING THE FIELD OF VIEW (FOV) BOARD FROM VERSION 2 TO VERSION 3.