Medical Device Manufacturer · US , Somerville , NJ

Roche Molecular Systems, Inc. - FDA 510(k) Cleared Devices

55 submissions · 52 cleared · Since 1993

Recent clearances: cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190), cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190), cobas® BV/CV

55
Total
52
Cleared
3
Denied
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