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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name data acquisition software
510(k) Number BK160113
Tradename cobas Synergy Software (Version 1.0)
Device Name Data acquisition software
Original Applicant
STRATEC Biomedical UK Limited
98 main street
suite 205
southington,  CT  06489
Regulation Number862.2570
Classification Product Code
PQQ  
Date Received11/10/2016
Decision Date 04/19/2017
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Microbiology
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 No
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