FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K Number: K946163
·
Decision Feb 22, 1995
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
319
Review Days
65
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Basic Information
- Device Name
- RADIAS TOTAL T4 ENZYME IMMUNOASSAY
- K Number
- K946163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Rad
- Date Received
- December 19, 1994
- Decision Date
- February 22, 1995
- Product Code
- KLI
- 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | FDA class 2 | Clinical Chemistry |
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