FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY
K Number: K955390
·
Decision Dec 29, 1995
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
35
Applicant Total
1
Review Days
35
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Basic Information
- Device Name
- INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY
- K Number
- K955390
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1370
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corning Nichols Diagnostics
- Date Received
- November 24, 1995
- Decision Date
- December 29, 1995
- Product Code
- CFL
- 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 |
|---|---|---|---|
| CFL | Radioimmunoassay, Human Growth Hormone | FDA class 1 | Clinical Chemistry |
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