FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROCHE ELECSYS ANTI-TG
K Number: K053426
·
Decision Feb 7, 2006
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
91
Applicant Total
264
Review Days
61
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Basic Information
- Device Name
- ROCHE ELECSYS ANTI-TG
- K Number
- K053426
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5870
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Corp.
- Date Received
- December 8, 2005
- Decision Date
- February 7, 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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