• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DevicePREPSTAIN SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Nameprocessor, cervical cytology slide, automated
Applicant
BD Diagnostic Systems
4025 stirrup creek drive
suite 400
durham, NC 27703
PMA NumberP970018
Supplement NumberS015
Date Received05/27/2009
Decision Date07/24/2009
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the changes made to the prepstain software program in response to recall z-1090-2009.
-
-