FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UIBC
K Number: K982041
·
Decision Jul 30, 1998
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
45
Applicant Total
857
Review Days
50
Basic Information
- Device Name
- UIBC
- K Number
- K982041
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ABBOTT LABORATORIES
- Date Received
- June 10, 1998
- Decision Date
- July 30, 1998
- Product Code
- JMO
- 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 |
|---|---|---|---|
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | FDA class 1 | Clinical Chemistry |
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