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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
ApplicantHOME ACCESS HEALTH CORP.
PMA NumberP980046
Supplement NumberS004
Date Received02/23/2001
Decision Date03/21/2001
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at home access health corporation, hoffman estates, illinois.
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