PMA P950009S016

Device
BD FOCALPOINT SLIDE PROFILER
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S016
Product code
MNM
Decision date
2012-08-30
Classification
Reader, Cervical Cytology Slide, Automated
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Approval order statement
APPROVAL FOR CHANGE OF THE SCAN CONTROLLER BOARD FOR THE DEVICE.

Current openFDA PMA Record#

Device
BD FOCALPOINT SLIDE PROFILER
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S016
Product code
MNM
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Decision date
2012-08-30
Decision code
APPR
Date received
2012-07-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR CHANGE OF THE SCAN CONTROLLER BOARD FOR THE DEVICE.