FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
FIDIS TM THYRO, MODEL MX002
K Number: K061794
·
Decision Nov 21, 2006
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
10
Review Days
148
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Basic Information
- Device Name
- FIDIS TM THYRO, MODEL MX002
- K Number
- K061794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomedical Diagnostics (Bmd) SA
- Date Received
- June 26, 2006
- Decision Date
- November 21, 2006
- Product Code
- JZO
- 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 |
|---|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | FDA class 2 | Immunology |
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Other Clearances by Biomedical Diagnostics (Bmd) SA
| K Number | Device Name | ||
|---|---|---|---|
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | Dec 3, 2010 | Substantially Equivalent |
| K100917 | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | Nov 3, 2010 | Substantially Equivalent |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | Dec 21, 2007 | Substantially Equivalent |
| K071210 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | Dec 19, 2007 | Substantially Equivalent |
| K060380 | FIDIS DSDNA | May 2, 2006 | Substantially Equivalent |
| K053383 | FIDIS CELIAC | Mar 29, 2006 | Substantially Equivalent |
| K053653 | FIDIS CONNECTIVE 10, MODEL MX006 | Mar 13, 2006 | Substantially Equivalent |
| K053012 | FIDIS VASCULITIS, MODEL MX007 | Mar 2, 2006 | Substantially Equivalent |
| K050286 | FIDIS CONNECTIVE 8 | Oct 3, 2005 | Substantially Equivalent |