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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameABBOTT IMX HAVAB-M LIST 2263
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameantibody to hepatitus a virus of igm class
Regulation Number866.3310
ApplicantABBOTT LABORATORIES
PMA NumberP790019
Supplement NumberS020
Date Received09/06/2005
Decision Date10/06/2005
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in quality controls that add a new specification, implemented to improve manufacturability without compromising product performance.
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