FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APOB
K Number: K983281
·
Decision Jan 26, 1999
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
42
Applicant Total
883
Review Days
130
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Basic Information
- Device Name
- APOB
- K Number
- K983281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5600
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- September 18, 1998
- Decision Date
- January 26, 1999
- Product Code
- DFC
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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FDA 510(k)
FDA Class 2
·Immunology
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