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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 NameHEPATITIS C CHECK TESTING SERVICE
Classification Nameassay,enzyme linked immunosorbent,hepatitis c virus
ApplicantHOME ACCESS HEALTH CORP.
PMA NumberP980046
Supplement NumberS002
Date Received03/23/2000
Decision Date04/12/2000
Product Code
MZO[ Registered Establishments with MZO ]
Advisory Committee Microbiology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
As a final packaging option, the outer packaging of the hepatitis c check product may be assembled in a softpak package or the currently approved paperboard packaging when shipped directly to clients.
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