FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESENSOR WARFARIN SENSITIVITY SALIVA TEST
K Number: K110786
·
Decision Dec 2, 2011
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
12
Applicant Total
1
Review Days
255
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Basic Information
- Device Name
- ESENSOR WARFARIN SENSITIVITY SALIVA TEST
- K Number
- K110786
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GenMark Diagnostics, Inc.
- Date Received
- March 22, 2011
- Decision Date
- December 2, 2011
- Product Code
- NSU
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | FDA class 2 | Clinical Chemistry |
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