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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.
 
DeviceABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)
Classification Namehepatitis delta serological reagents
Generic Namehepatitis delta serological reagents
Applicant
Abbott Laboratories
100 abbott park rd.
abbott park, IL 60064-3500
PMA NumberP850062
Date Received08/29/1985
Decision Date07/01/1986
Withdrawal Date 03/22/2007
Product Code
LQI[ Registered Establishments with LQI ]
Docket Number 86M-0308
Notice Date 08/07/1986
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 
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