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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.
 
DeviceABBOTT ARCHITECT ANTI-HCV
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantABBOTT LABORATORIES INC
100 ABBOTT PARK ROAD
AP5N-2, DEPT 09VB
ABBOTT PARK, IL 60064
PMA NumberP050042
Supplement NumberS003
Date Received10/29/2007
Decision Date12/10/2007
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE OUTPUT OF THE ASSAY FILE INTERPRETATION SCREEN.
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