FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
FIDIS CELIAC
K Number: K041002
·
Decision Sep 24, 2004
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
41
Applicant Total
1
Review Days
158
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Basic Information
- Device Name
- FIDIS CELIAC
- K Number
- K041002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5750
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomedical Diagnostics S.A.
- Date Received
- April 19, 2004
- Decision Date
- September 24, 2004
- Product Code
- MST
- 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 |
|---|---|---|---|
| MST | Antibodies, Gliadin | FDA class 2 | Immunology |
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