FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTIMUNE NEONATAL & THYROXINE RIA
K Number: K771135
·
Decision Jul 14, 1977
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
120
Applicant Total
318
Review Days
21
Basic Information
- Device Name
- QUANTIMUNE NEONATAL & THYROXINE RIA
- K Number
- K771135
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- BIO-RAD
- Date Received
- June 23, 1977
- Decision Date
- July 14, 1977
- Product Code
- CDX
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | FDA class 2 | Clinical Chemistry |
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