cobas vivoDx MRSA— 510(k) DEN190016
UnknownRoche Molecular Systems, Inc.
FDA 510(k) clearance DEN190016 for cobas vivoDx MRSA, Unknown on 2019-12-05. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code QIV
- Device class
- Class 2
- Regulation
- 21 CFR 866.1655
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Pleasanton, CA, US
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