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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.
 
DeviceHA-IGMK AND ETI-HA-IGMK
Classification Namehepatitis a test (antibody and igm antibody)
Generic Namehepatitis a test (antibody and igm antibody)
Regulation Number866.3310
Applicant
DIASORIN, INC.
1951 northwestern ave.
stillwater, MN 55082-0285
PMA NumberP890014
Date Received03/10/1989
Decision Date07/24/1990
Reclassified Date 02/09/2006
Product Code
LOL[ Registered Establishments with LOL ]
Docket Number 90M-0251
Notice Date 08/10/1990
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S002 S003 S004 S005 S007 S008 
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