FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KODAK AMERLITE MAB FT3 ASSAY
K Number: K922713
·
Decision Oct 26, 1992
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
91
Applicant Total
238
Review Days
143
Basic Information
- Device Name
- KODAK AMERLITE MAB FT3 ASSAY
- K Number
- K922713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EASTMAN KODAK COMPANY
- Date Received
- June 5, 1992
- Decision Date
- October 26, 1992
- 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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