cobas Factor II and Factor V Test— 510(k) K172913
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K172913 for cobas Factor II and Factor V Test, Substantially Equivalent on 2018-01-12. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code NPR
- Device class
- Class 2
- Regulation
- 21 CFR 864.7280
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
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