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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.
 
DeviceABBOTT IMX(R) HAVAB(R)-M
Classification Namehepatitis a test (antibody and igm antibody)
Generic Namehepatitis a test (antibody and igm antibody)
Regulation Number866.3310
Applicant
Abbott Laboratories
d-49c, building ap6c
100 abbott park road
abbott park north, IL 60064-3500
PMA NumberP790019
Supplement NumberS010
Date Received06/20/1997
Decision Date07/24/1997
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the evaluation of the havab-m eia conjugate concentrate, positive control from a sample to standard ratio to a sample to target ratio.
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