cobas Cdiff Test— 510(k) K142422
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K142422 for cobas Cdiff Test, Substantially Equivalent on 2015-05-20. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code OZN
view all- K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more
- K243730 — Xpert C. difficile/Epi
- K232092 — Great Basin Toxigenic C. difficile Direct Test (CDF2)
- K212427 — cobas Cdiff nucleic acid test for use on the cobas Liat System
- K210385 — cobas Cdiff nucleic acid test for use on the cobas Liat System
More clearances from Roche Molecular Systems, Inc.
view all- K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more
- K260021 — cobas® BV/CV
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- 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.