• 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.
 
DeviceIMMULITE PSA CATALOG # LKPS1,5)
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate-specific antigen (psa) for management of prostate cancers
Regulation Number866.6010
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
glyn rhonwy, llanberis
gwynedd ll55 4el LL554
PMA NumberP930027
Supplement NumberS003
Date Received02/20/1998
Decision Date05/08/1998
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding information on the percentage for each psa range for healthy male subjects as one group in the expected value section.
-
-