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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS
Classification Nameantigen(complexed),prostate specific,(cpsa)
ApplicantONCOGENE SCIENCE BAYER HEALTHCARE LLC
PMA NumberP990055
Supplement NumberS006
Date Received04/21/2003
Decision Date05/09/2003
Product Code
NAF[ Registered Establishments with NAF ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the acs: 180 and advia centaur complexed psa (cpsa) immunoassays.
-
-