• 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 | Inspections
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 NameELECSYS FREE PSA IMMUNOASSAY
Classification Nametest,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP000027
Supplement NumberS013
Date Received11/22/2011
Decision Date12/21/2011
Product Code
MTG[ Registered Establishments with MTG ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the intermediate storage form coating process of the elecsys coated microparticles (beads).
-
-