Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAUTOCYTE PREP SYSTEM
Generic NameProcessor, cervical cytology slide, automated
ApplicantBD Diagnostic Systems
4025 STIRRUP CREEK DRIVE
SUITE 400
DURHAM, NC 27703
PMA NumberP970018
Supplement NumberS002
Date Received12/01/2000
Decision Date05/25/2001
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE PREPMATE ACCESSORY (PREPMATE METHOD), WHICH AUTOMATES THE INITIAL MANUAL STEPS OF THE AUTOCYTE PREP LABORATORY PROCESS. THE PREPMATE AUTOMATICALLY MIXES AND REMOVES THE SPECIMEN FROM THE GYN PRESERVATIVE VIALS, AND LAYERS THE SPECIMEN ONTO CYTORICH DENSITY REAGENT IN A TEST TUBE, AND FOR THE ADDITION OF THE MANUAL METHOD, IN WHICH, RATHER THAN USING THE AUTOCYTE PREP SYSTEM FOR CELL SUSPENSION AND SLIDE STAINING, THE CELL SUSPENSION IS MANUALLY LAYERED ONTO THE SLIDE AND STAINED BY A LABORATORY TECHNICIAN.
-
-