• 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
 
Trade NameCA 125 ANTIBODY RIA
Classification Nametest, epithelial ovarian tumor-associated antigen (ca125)
Generic Nameepithelial ovarian tumor-associated antigen (ca1
Regulation Number866.6010
ApplicantCENTOCOR, INC.
PMA NumberP850009
Supplement NumberS002
Date Received10/27/1989
Decision Date02/13/1990
Product Code
LTK[ Registered Establishments with LTK ]
Advisory Committee Immunology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
-
-