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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 x 480, cobas HPV Test, 240/960 Tests
Generic Namekit, dna detection, human papillomavirus
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP100020
Supplement NumberS032
Date Received05/09/2018
Decision Date08/08/2018
Product Code MAQ 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the manufacturer, design, and specifications of the heater/shaker unit of the cobas 480 x Instrument, a component of the cobas 4800 System.
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