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 NameELECSYS TOTAL PSA IMMUNOASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Nameelectrochemiluminescence assay for the determination of prostate specific antigen;psa calibrator
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP990056
Supplement NumberS012
Date Received04/25/2011
Decision Date05/24/2011
Product Code
MTF[ Registered Establishments with MTF ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in manufacturing site from buildings 351/352 to building 761, all within the roche penzberg, germany facility for production of a component (biotinylated- and ruthenium-labeled antibodies or conjugated antibodies) used in this assay.
-
-