• 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 | Inspections

New Search Back to Search Results
Classification Namesystem, test, carcinoembryonic antigen
Generic Nameabbott cea-ria monoclonal assay
Regulation Number866.6010
PMA NumberP830066
Supplement NumberS012
Date Received06/14/1995
Decision Date07/12/1995
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the package labeling to decrease the "hook" value from 100,00 to 60,000 ng cea/ml.