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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHAVAB-M DIAGNOSTIC KIT
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameantibody to hepatitus a virus of igm class
Regulation Number866.3310
ApplicantABBOTT LABORATORIES
PMA NumberP790019
Date Received08/27/1979
Decision Date06/10/1980
Reclassified Date 02/09/2006
Product Code
LOL[ Registered Establishments with LOL ]
Docket Number 80M-0366
Notice Date 11/21/1980
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 
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