FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
K Number: K210234
·
Decision Feb 16, 2021
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
77
Applicant Total
28
Review Days
19
Basic Information
- Device Name
- cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
- K Number
- K210234
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Molecular Systems, Inc.
- Date Received
- January 28, 2021
- Decision Date
- February 16, 2021
- Product Code
- OCC
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCC), ordered by most recent decision date.
NxTAG® Respiratory Pathogen Panel
FDA 510(k)
FDA Class 2
·Microbiology
ID NOW Influenza A & B 2
FDA 510(k)
FDA Class 2
·Microbiology
Panther Fusion AdV/hMPV/RV Assay
FDA 510(k)
FDA Class 2
·Microbiology
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Roche Molecular Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243863 | Opulus Lymphoma Precision | May 30, 2025 | Substantially Equivalent |
| K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | Apr 25, 2025 | Substantially Equivalent |
| K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | Apr 25, 2025 | Substantially Equivalent |
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | Apr 11, 2025 | Substantially Equivalent |
| K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | Feb 11, 2025 | Substantially Equivalent |
| K240217 | cobas® liat CT/NG nucleic acid test | Jan 17, 2025 | Substantially Equivalent |
| K240197 | cobas® liat CT/NG/MG nucleic acid test | Jan 16, 2025 | Substantially Equivalent |
| K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Dec 4, 2023 | Substantially Equivalent |
| K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System | Jul 27, 2023 | Substantially Equivalent |
| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | Jun 1, 2023 | Substantially Equivalent |