FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T4-RIA KIT
K Number: K780707
·
Decision Jun 14, 1978
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
4
Review Days
50
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Basic Information
- Device Name
- T4-RIA KIT
- K Number
- K780707
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Bioresearch
- Date Received
- April 25, 1978
- Decision Date
- June 14, 1978
- Product Code
- CDX
- 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | FDA class 2 | Clinical Chemistry |
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