FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elecsys FT4 IV
K Number: K220456
·
Decision Apr 7, 2023
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
91
Applicant Total
183
Review Days
414
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Basic Information
- Device Name
- Elecsys FT4 IV
- K Number
- K220456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- February 17, 2022
- Decision Date
- April 7, 2023
- Product Code
- CEC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | Clinical Chemistry |
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