FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CoaguChek Vantus System
K Number: K170960
·
Decision Dec 25, 2017
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
126
Applicant Total
183
Review Days
269
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Basic Information
- Device Name
- CoaguChek Vantus System
- K Number
- K170960
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7750
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- March 31, 2017
- Decision Date
- December 25, 2017
- Product Code
- GJS
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GJS | Test, Time, Prothrombin | FDA class 2 | Hematology |
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