|
Device | BD FOCAL POINT SLIDE PROFILER |
Generic Name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
Applicant | BD DIAGNOSTICS 4025 STIRRUP CREEK DRIVE SUITE 400 DURHAM, NC 27703 |
PMA Number | P950009 |
Supplement Number | S017 |
Date Received | 12/02/2013 |
Decision Date | 02/26/2014 |
Product Code |
MNM |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REPLACEMENT OF THE CURRENT SCAN CONTROLLER BOARD (SCB) UTILIZED IN THE BD FOCALPOINT¿ SLIDE PROFILER WITH DIGITAL IMAGE SYSTEM CONFIGURATION. |