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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.
Classification Namehepatitis a test (antibody and igm antibody)
Generic Nameantibody to hepatitus a virus of igm class
Regulation Number866.3310
PMA NumberP790019
Supplement NumberS009
Date Received04/23/1997
Decision Date05/28/1997
Product Code
LOL[ Registered Establishments with LOL ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the specifications for the positive control sample to standard ratio from 0. 90-1. 15 to 0. 85-1. 15, and a change in the evaluation of the hepatitis a virus solution and the havab(r)-m eia conjugate from a sample to standard ratio to a sample to target ratio.