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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 SERVICE
Classification Nametubes, vials, systems, serum separators, blood collection
Regulation Number862.1675
ApplicantHOME ACCESS HEALTH CORP.
PMA NumberP980046
Supplement NumberS006
Date Received05/28/2003
Decision Date09/08/2003
Product Code
JKA[ Registered Establishments with JKA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at fitzco, inc. , spring park, minnesota.
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