• 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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTANDEM-R PSA IMMUNORADIOMETRIC ASSAY
Classification Nametotal,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer
Generic Namepsa immunoradiometric assay
ApplicantBECKMAN COULTER, INC.
PMA NumberP850048
Date Received07/09/1985
Decision Date02/25/1986
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 86M-0137
Notice Date 04/09/1986
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S031 S032 S033 S034 S035 S036 S037 
-
-