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) | 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 Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceABBOTT CEA-RIA MONOCLONAL
Generic NameSYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
Regulation Number866.6010
ApplicantAbbott Laboratories
Dept: 09v8 Bldg: Ap5-2
100 Abbott Park Rd.
Abbott Park, IL 60064
PMA NumberP830066
Supplement NumberS012
Date Received06/14/1995
Decision Date07/12/1995
Product Code DHX 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE PACKAGE LABELING TO DECREASE THE "HOOK" VALUE FROM 100,00 TO 60,000 NG CEA/ML
-
-