cobas HCV— 510(k) K221007
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K221007 for cobas HCV, Substantially Equivalent on 2022-11-04. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code MZP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3170
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code MZP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.