FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
K Number: K213858
·
Decision Jul 26, 2022
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
71
Review Days
228
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Basic Information
- Device Name
- LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
- K Number
- K213858
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5180
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DiaSorin, Inc.
- Date Received
- December 10, 2021
- Decision Date
- July 26, 2022
- Product Code
- NXO
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| NXO | Calprotectin, Fecal | FDA class 2 | Immunology |
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