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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.
 
DeviceHEPATITIS C CHECK TESTING SERVICE
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 NumberS002
Date Received03/23/2000
Decision Date04/12/2000
Product Code MZO 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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