FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
OCTEIA IGF-1 KIT
K Number: K950510
·
Decision Apr 5, 1995
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
35
Applicant Total
23
Review Days
58
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Basic Information
- Device Name
- OCTEIA IGF-1 KIT
- K Number
- K950510
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1370
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Immunodiagnostic Systems , Ltd.
- Date Received
- February 6, 1995
- Decision Date
- April 5, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFL), ordered by most recent decision date.
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY
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HUMAN GROWTH HORMONE IMMUNOASSAY KIT
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DSL ACTIVE NON-EXTRACTION IGF-I IRMA
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·Clinical Chemistry
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