FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
BUHLMANN fCAL ELISA
K Number: K181012
·
Decision Jun 4, 2018
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
4
Review Days
48
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Basic Information
- Device Name
- BUHLMANN fCAL ELISA
- K Number
- K181012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5180
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Buhlmann Laboratories AG
- Date Received
- April 17, 2018
- Decision Date
- June 4, 2018
- 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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