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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
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameantibody to hepatitis a virus 125i (human)
Regulation Number866.3310
ApplicantABBOTT LABORATORIES
PMA NumberP780012
Date Received11/03/1978
Decision Date01/19/1979
Reclassified Date 02/09/2006
Product Code
LOL[ Registered Establishments with LOL ]
Docket Number 79M-0145
Notice Date 05/15/1979
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 
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