FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXSYM CA 125
K Number: K964020
·
Decision Nov 4, 1997
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
25
Applicant Total
883
Review Days
393
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Basic Information
- Device Name
- AXSYM CA 125
- K Number
- K964020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- October 7, 1996
- Decision Date
- November 4, 1997
- Product Code
- LTK
- 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 |
|---|---|---|---|
| LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | FDA class 2 | Immunology |
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