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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHOME ACCESS HEPATITIS C CHECK TEST SYSTEM
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantPwn Health Chicago, LLC
123 W 18th St.
New York, NY 10002
PMA NumberP980046
Supplement NumberS008
Date Received08/01/2011
Decision Date08/31/2011
Product Code MZO 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
NEW SUPPLIER FOR THE BARRIER POUCH COMPONENT OF THE DEVICE.
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