cobas Cdiff Nucleic acid test for use on the cobas Liat System— 510(k) K171770
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K171770 for cobas Cdiff Nucleic acid test for use on the cobas Liat System, Substantially Equivalent on 2017-09-12. 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.