FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABBOTT IMX 2 ANALYZER
K Number: K944731
·
Decision Dec 19, 1994
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
883
Review Days
98
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Basic Information
- Device Name
- ABBOTT IMX 2 ANALYZER
- K Number
- K944731
- 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
- September 12, 1994
- Decision Date
- December 19, 1994
- Product Code
- JJI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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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