PMA P950009S019

Device
BD FOCALPOINT SLIDE PROFILER
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S019
Product code
MNM
Decision date
2015-07-23
Classification
Reader, Cervical Cytology Slide, Automated
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Approval order statement
APPROVAL FOR A REPLACEMENT WORKSTATION AND SOFTWARE MODIFICATIONS FOR THE BD FOCALPOINT SLIDE PROFILER.

Current openFDA PMA Record#

Device
BD FOCALPOINT SLIDE PROFILER
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S019
Product code
MNM
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Decision date
2015-07-23
Decision code
APPR
Date received
2015-04-24
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A REPLACEMENT WORKSTATION AND SOFTWARE MODIFICATIONS FOR THE BD FOCALPOINT SLIDE PROFILER.