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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.
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