Roche Molecular Systems, Inc. is one of 12957 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Roche Molecular Systems, Inc. has 52 FDA 510(k) cleared microbiology devices. Based in Somerville, US.
Latest FDA clearance: Aug 2026. Active since 1993.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Roche Molecular Systems, Inc.
55 devices
Cleared
Aug 28, 2026
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190)
Microbiology
233d
Cleared
Aug 28, 2026
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190)
Microbiology
233d
Cleared
Jul 16, 2026
cobas® BV/CV
Microbiology
192d
Cleared
Jul 08, 2026
cobas CT/NG for use on the cobas 5800/6800/8800 systems
Microbiology
111d
Cleared
May 15, 2026
cobas liat CT/NG nucleic acid test
Microbiology
171d
Cleared
May 15, 2026
cobas liat CT/NG/MG nucleic acid test
Microbiology
171d
Cleared
Nov 20, 2025
cobas liat Bordetella panel nucleic acid test
Microbiology
350d
Cleared
Nov 03, 2025
cobas CMV
Microbiology
88d
Cleared
Nov 03, 2025
cobas HCV
Microbiology
88d
Cleared
Jul 31, 2025
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
Microbiology
266d
Cleared
May 30, 2025
Opulus™ Lymphoma Precision
Radiology
164d
Cleared
Apr 25, 2025
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
Microbiology
176d
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