FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMX INSULIN
K Number: K920109
·
Decision May 7, 1992
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
883
Review Days
118
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Basic Information
- Device Name
- IMX INSULIN
- K Number
- K920109
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1405
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Abbott Laboratories
- Date Received
- January 10, 1992
- Decision Date
- May 7, 1992
- Product Code
- CFP
- 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 |
|---|---|---|---|
| CFP | Radioimmunoassay, Immunoreactive Insulin | FDA class 1 | Clinical Chemistry |
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