Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

49 results for "Roche Molecular Systems, Inc."
1–24 of 49
Cleared Nov 20, 2025
cobas liat Bordetella panel nucleic acid test
K243753 · OZZ
Roche Molecular Systems, Inc.
Microbiology · 350d
Cleared Nov 03, 2025
cobas HCV
K252484 · MZP
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Nov 03, 2025
cobas CMV
K252481 · PAB
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Jul 31, 2025
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
K243455 · QOF
Roche Molecular Systems, Inc.
Microbiology · 266d
Cleared May 30, 2025
Opulus™ Lymphoma Precision
K243863 · QIH
Roche Molecular Systems, Inc.
Radiology · 164d
Cleared Apr 25, 2025
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
K243406 · QOF
Roche Molecular Systems, Inc.
Microbiology · 175d
Cleared Apr 25, 2025
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
K243400 · QOF
Roche Molecular Systems, Inc.
Microbiology · 176d
Cleared Apr 11, 2025
cobas liat SARS-CoV-2 v2 nucleic acid test
K243346 · QWR
Roche Molecular Systems, Inc.
Microbiology · 165d
Cleared Feb 11, 2025
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
K240867 · QQX
Roche Molecular Systems, Inc.
Microbiology · 319d
Cleared Jan 17, 2025
cobas® liat CT/NG nucleic acid test
K240217 · QEP
Roche Molecular Systems, Inc.
Microbiology · 357d
Cleared Jan 16, 2025
cobas® liat CT/NG/MG nucleic acid test
K240197 · QEP
Roche Molecular Systems, Inc.
Microbiology · 357d
Cleared Dec 04, 2023
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
K223783 · QWR
Roche Molecular Systems, Inc.
Microbiology · 353d
Cleared Jul 27, 2023
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas®...
K223591 · QOF
Roche Molecular Systems, Inc.
Microbiology · 238d
Cleared Jun 01, 2023
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
K231306 · QQX
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Nov 04, 2022
cobas HCV
K221007 · MZP
Roche Molecular Systems, Inc.
Microbiology · 213d
Cleared Oct 22, 2022
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
K213804 · QQX
Roche Molecular Systems, Inc.
Microbiology · 320d
Cleared Jul 06, 2022
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
K213822 · OCC
Roche Molecular Systems, Inc.
Microbiology · 210d
Cleared Oct 20, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K212427 · OZN
Roche Molecular Systems, Inc.
Microbiology · 77d
Cleared Sep 09, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385 · OZN
Roche Molecular Systems, Inc.
Microbiology · 212d
Cleared Feb 16, 2021
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
K210234 · OCC
Roche Molecular Systems, Inc.
Microbiology · 19d
Cleared Jan 29, 2021
cobas BKV
K203220 · QLX
Roche Molecular Systems, Inc.
Microbiology · 88d
Cleared Jan 21, 2021
cobas CTNG for use on cobas 6800/8800 systems
K202408 · QEP
Roche Molecular Systems, Inc.
Microbiology · 153d
Cleared Sep 02, 2020
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
K202215 · QMI
Roche Molecular Systems, Inc.
Microbiology · 27d
Not Cleared Jul 30, 2020
cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
DEN200015 · QLX
Roche Molecular Systems, Inc.
Microbiology · 150d