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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 NameCOBAS AMPLICOR HCV TEST, V2.0
ApplicantROCHE MOLECULAR SYSTEMS, INC.
PMA NumberP000010
Supplement NumberS001
Date Received09/21/2001
Decision Date10/12/2001
Advisory Committee Microbiology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in quality control specifications.
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