Roche Molecular Systems, Inc. is one of 5511 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® BV/CV, cobas CT/NG for use on the cobas 5800/6800/8800 systems, cobas liat CT/NG nucleic acid test
53
Total
50
Cleared
3
Denied
Roche Molecular Systems, Inc. has 50 FDA 510(k) cleared microbiology devices. Based in Somerville, US.
Latest FDA clearance: Jul 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.
53 devices
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
Cleared
Apr 25, 2025
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
Microbiology
175d
Cleared
Apr 11, 2025
cobas liat SARS-CoV-2 v2 nucleic acid test
Microbiology
165d
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