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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 NameHA-IGMK AND ETI-HA-IGMK
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameradioimmunoassay kit
Regulation Number866.3310
ApplicantDIASORIN, INC.
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
Supplements: S001 S002 S003 S004 S005 S007 
S008 
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