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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.
 
DeviceELECSYS ANTI-HCV ON COBAS E 601
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP090008
Supplement NumberS009
Date Received02/29/2012
Decision Date03/28/2012
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
TRANSFER OF THE REWORK ACTIVITIES FOR THE ELECSYS REAGENT KITS FROM BUILDING R TO BUILDING W2 ON THE INDIANAPOLIS CAMPUS.
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