FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THYROID UPTAKE SYSTEM
K Number: K833140
·
Decision Dec 8, 1983
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
29
Applicant Total
1
Review Days
85
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Basic Information
- Device Name
- THYROID UPTAKE SYSTEM
- K Number
- K833140
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1320
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Advanced Medical Research Corp.
- Date Received
- September 14, 1983
- Decision Date
- December 8, 1983
- Product Code
- IZD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | FDA class 1 | Radiology |
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