cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems— 510(k) K240867
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K240867 for cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems, Substantially Equivalent on 2025-02-11. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code QQX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3981
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code QQX
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Data sourced from openFDA. This site is unofficial and independent of the FDA.