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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceHAVAB
Generic NameHepatitis a test (antibody and igm antibody)
Regulation Number866.3310
ApplicantAbbott Laboratories
100 ABBOTT PARK ROAD
D-049C/AP6C-2
ABBOTT PARK, IL 60064
PMA NumberP780012
Date Received11/03/1978
Decision Date01/19/1979
Reclassified Date 02/09/2006
Product Code LOL 
Docket Number 79M-0145
Notice Date 05/15/1979
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 
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