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 NameAXSYM TOTAL PSA (LN 3C19)
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameimmunochemistry analyzer
ApplicantABBOTT LABORATORIES
PMA NumberP910007
Supplement NumberS032
Date Received11/02/2011
Decision Date12/22/2011
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for relocation of bulk solution preparation to new manufacturing spaces in a building located within the same manufacturing facilities.
-
-