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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, equipment, automated bloodborne pathogen
510(k) Number BK140195
Tradenames Cobas ® 8800 System, Cobas p 680 Instrument
Device Name Test, Equipment, Automated Bloodborne Pathogen
Original Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
p.o. box 9002
pleasanton,,  CA  94588 0900
Classification Product Code
MZA  
Date Received11/13/2014
Decision Date 10/20/2016
Decision substantially equivalent (SE)
Review Advisory Committee Immunology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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