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— 510(k) K200065
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K200065 for 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, Substantially Equivalent on 2020-02-10. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code OCC
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code OCC
view allMore clearances from Roche Molecular Systems, Inc.
view all- K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more
- K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more
- K260021 — cobas® BV/CV
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- K253756 — cobas liat CT/NG nucleic acid test
Adverse events under product code OCC
product code OCC- Death
- 3
- Malfunction
- 706
- Total
- 709
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.