FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APOLIPOPROTEIN A1
K Number: K983289
·
Decision Jan 29, 1999
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
16
Applicant Total
883
Review Days
133
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Basic Information
- Device Name
- APOLIPOPROTEIN A1
- K Number
- K983289
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5580
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- September 18, 1998
- Decision Date
- January 29, 1999
- Product Code
- DER
- 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 |
|---|---|---|---|
| DER | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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