FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMOPHASE INSULIN (125I) RADIOASSAY
K Number: K811953
·
Decision Jul 23, 1981
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
111
Review Days
15
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Basic Information
- Device Name
- IMMOPHASE INSULIN (125I) RADIOASSAY
- K Number
- K811953
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1405
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Corning Medical & Scientific
- Date Received
- July 8, 1981
- Decision Date
- July 23, 1981
- Product Code
- CFP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| CFP | Radioimmunoassay, Immunoreactive Insulin | FDA class 1 | Clinical Chemistry |
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