• 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.
 
DeviceIMX HAVAB -M (LIST NUMBER 2263)
Classification Namehepatitis a test (antibody and igm antibody)
Generic Namehepatitis a test (antibody and igm antibody)
Regulation Number866.3310
Applicant
Abbott Laboratories
d-49c, building ap6c
100 abbott park road
abbott park north, IL 60064-3500
PMA NumberP790019
Supplement NumberS017
Date Received10/08/2003
Decision Date11/06/2003
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
DISCONTINUE THE USE OF REFERENCE PANEL 4 AND ELIMINATE ALL ASSOCIATED VALIDITY AND ACCEPTANCE CRITERIA FROM BOTH THE INCOMING ALKALINE PHOSPHATASE AND THE IMX HAVAB-M CONJUGATE CONCENTRATE TESTING.
-
-