|
Device | BD FOCALPOINT 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 | S011 |
Date Received | 12/10/2009 |
Decision Date | 01/08/2010 |
Product Code |
MNM |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement NEW VENDOR OF A COMPONENT PROGRAMMED TO CONTROL DIFFERENT ASPECTS OF THE IMAGE PROCESSING. |