FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS
K Number: K812786
·
Decision Oct 23, 1981
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
86
Applicant Total
111
Review Days
18
Basic Information
- Device Name
- FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS
- K Number
- K812786
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- CORNING MEDICAL & SCIENTIFIC
- Date Received
- October 5, 1981
- Decision Date
- October 23, 1981
- Product Code
- DBF
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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