cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems— 510(k) K231306
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K231306 for cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems, Substantially Equivalent on 2023-06-01. Applicant: Roche Molecular Systems, Inc..
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code QQX
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pleasanton, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.