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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.
 
DeviceCOBAS HPC TEST,240 TESTS AND COBAS HPV TEST, 960 TESTS
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP100020
Supplement NumberS015
Date Received06/24/2015
Decision Date07/23/2015
Product Code MAQ 
Advisory Committee Microbiology
Clinical TrialsNCT00709891
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
REMOVAL OF INCOMING ACCEPTANCE TESTING FOR TWO RAW MATERIALS.
Post-Approval StudyShow Report Schedule and Study Progress
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