cobas® CT/NG v2.0 Test— 510(k) K163184
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K163184 for cobas® CT/NG v2.0 Test, Substantially Equivalent on 2017-02-09. Applicant: Roche Molecular Systems, Inc..
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code LSL
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.