• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • 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 show TPLC since Back to Search Results
Device prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
Definition Determines rate of increase of total prostate specific antigen at ultrasensitive concentration levels (picogram/ml serum), and identifies those patients following prostatectomies which are at reduced risk for recurrence of prostate cancer.
Product CodeOWM
Regulation Number 866.6040
Device Class 2