cobas Cdiff nucleic acid test for use on the cobas Liat System— 510(k) K210385
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K210385 for cobas Cdiff nucleic acid test for use on the cobas Liat System, Substantially Equivalent on 2021-09-09. 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
- Special
- Location
- Pleasanton, CA, US
Recent devices under product code OZN
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