cobas CTNG for use on cobas 6800/8800 systems— 510(k) K202408
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K202408 for cobas CTNG for use on cobas 6800/8800 systems, Substantially Equivalent on 2021-01-21. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Product code QEP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3393
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code QEP
view allMore clearances from Roche Molecular Systems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.