cobas® BV/CV— 510(k) K260021
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K260021 for cobas® BV/CV, Substantially Equivalent on 2026-07-16. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code PQA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3975
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code PQA
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- K253756 — cobas liat CT/NG nucleic acid test
- K253759 — cobas liat CT/NG/MG nucleic acid test
Data sourced from openFDA. This site is unofficial and independent of the FDA.