• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 
Trade NameCEA-ROCHE TEST KIT
Classification Namesystem, test, carcinoembryonic antigen
Generic Namecea kit
Regulation Number866.6010
ApplicantHOFFMANN-LA ROCHE, INC.
PMA NumberP800063
Supplement NumberS003
Date Received09/15/1982
Decision Date10/21/1982
Product Code
DHX[ Registered Establishments with DHX ]
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
-
-