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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 Namekit, dna detection, human papillomavirus
ApplicantHOLOGIC, INC.
PMA NumberP080014
Supplement NumberS004
Date Received10/05/2010
Decision Date10/26/2010
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in the fill volume of the wash buffer and an increase in sample size of the incoming components being tested.