cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System— 510(k) K223591
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K223591 for cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System, Substantially Equivalent on 2023-07-27. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product code QOF
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Pleasanton, CA, US
Recent devices under product code QOF
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Data sourced from openFDA. This site is unofficial and independent of the FDA.