Roche Molecular Systems, Inc. - FDA 510(k) Cleared Devices
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
FDA 510(k) Regulatory Record - Roche Molecular Systems, Inc. Hematology ✕
1 devices