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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 TEST SERVICE
Classification Nametubes, vials, systems, serum separators, blood collection
Regulation Number862.1675
ApplicantHOME ACCESS HEALTH CORP.
PMA NumberP980046
Supplement NumberS005
Date Received10/24/2002
Decision Date12/06/2002
Product Code
JKA[ Registered Establishments with JKA ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a reduction of a supplement testing range (str) from specimens with a signal-to-cutoff value from 5. 0 to 4. 2.
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