FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALPREST
K Number: K130945
·
Decision Jan 16, 2014
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
4
Review Days
287
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CALPREST
- K Number
- K130945
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5180
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eurospital S.P.A.
- Date Received
- April 4, 2013
- Decision Date
- January 16, 2014
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NXO), ordered by most recent decision date.
BÜHLMANN fCAL® turbo and CALEX® Cap
FDA 510(k)
FDA Class 2
·Immunology
ALPCO Calprotectin Immunoturbidimetric Assay
FDA 510(k)
FDA Class 2
·Immunology
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
FDA 510(k)
FDA Class 2
·Immunology
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
FDA 510(k)
FDA Class 2
·Immunology
Buhlmann fCAL turbo and CALEX Cap
FDA 510(k)
FDA Class 2
·Immunology
Calprest, EasyCal
FDA 510(k)
FDA Class 2
·Immunology