|
Device | BD FOCALPOINT GS IMAGING SYSTEM |
Generic Name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
Applicant | BD DIAGNOSTICS 4025 STIRRUP CREEK DRIVE SUITE 400 DURHAM, NC 27703 |
PMA Number | P950009 |
Supplement Number | S010 |
Date Received | 06/25/2009 |
Decision Date | 03/15/2010 |
Product Code |
MNM |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT TRIPATH IMAGING, INC. IN MELBANE, NORTH CAROLINA. |