|
Device | BD PREPMATE SLIDE PROCESSOR, BD PREPMATE AUTOMATED ACCESSORY |
Generic Name | Processor, cervical cytology slide, automated |
Applicant | BD Diagnostic Systems 4025 STIRRUP CREEK DRIVE SUITE 400 DURHAM, NC 27703 |
PMA Number | P970018 |
Supplement Number | S031 |
Date Received | 01/22/2015 |
Decision Date | 06/14/2015 |
Product Code |
MKQ |
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 |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED SPARKS, MD. |