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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.
DeviceAB -HAVK
Classification Namehepatitis a test (antibody and igm antibody)
Generic Namehepatitis a test (antibody and igm antibody)
Regulation Number866.3310
1951 northwestern avenue
po box 285
stillwater, MN 55082-0285
PMA NumberP890019
Date Received03/15/1989
Decision Date07/13/1990
Reclassified Date 02/09/2006
Product Code
LOL[ Registered Establishments with LOL ]
Docket Number 90m-0245
Notice Date 10/01/1990
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S005 S006 S007 S009 S011 S012