• 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.
 
DeviceAUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
Classification Namereader, cervical cytology slide, automated
Generic Namereader, cervical cytology slide, automated
Applicant
BD DIAGNOSTICS
4025 stirrup creek drive
suite 400
durham, NC 27703
PMA NumberP950009
Supplement NumberS001
Date Received11/06/1995
Decision Date04/25/1996
Product Code
MNM[ Registered Establishments with MNM ]
Advisory Committee Pathology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes made to the manual to improve how the report forms will look, for clarity.
-
-