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 NameTANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY
Classification Nameprostate-specific antigen (psa) for management of prostate cancers
Generic Nameprostate_specific antigen (psa) for management of prostate cancer
Regulation Number866.6010
ApplicantHYBRITECH, INC.
PMA NumberP850048
Supplement NumberS012
Date Received10/27/1995
Decision Date05/03/1996
Product Code
LTJ[ Registered Establishments with LTJ ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in hybritech's immunoenzymetric psa assay from a bead format to a microplate (mp) format (tandem-mp psa assay).
-
-