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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 NameHOME ACCESS HEPATITIS C CHECK TEST SYSTEM
ApplicantHOME ACCESS HEALTH CORP.
PMA NumberP980046
Supplement NumberS008
Date Received08/03/2011
Decision Date08/31/2011
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New supplier for the barrier pouch component of the device.
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