Premarket Approval (PMA)

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.

• Device: HOME ACCESS HEPATITIS C CHECK TEST SERVICE
• Generic Name: Assay, enzyme linked immunosorbent, hepatitis c virus
• Regulation Number: 866.3169
• Applicant: Pwn Health Chicago, LLC; 123 W 18th St.; New York, NY 10002
• PMA Number: P980046
• Supplement Number: S006
• Date Received: 05/28/2003
• Decision Date: 09/08/2003
• Product Code: MZO
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT FITZCO, INC., SPRING PARK, MINNESOTA.