FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABBOTT IMX2 ANALYER
K Number: K931970
·
Decision Jun 16, 1993
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
883
Review Days
55
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Basic Information
- Device Name
- ABBOTT IMX2 ANALYER
- K Number
- K931970
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2500
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- April 22, 1993
- Decision Date
- June 16, 1993
- Product Code
- JJI
- 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 |
|---|---|---|---|
| JJI | Analyzer, Enzyme, For Clinical Use | FDA class 1 | Clinical Chemistry |
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