FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAS CA 15-3 ASSAY
K Number: K080469
·
Decision Jun 22, 2009
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
25
Applicant Total
251
Review Days
487
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Basic Information
- Device Name
- VIDAS CA 15-3 ASSAY
- K Number
- K080469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- bioMerieux, Inc.
- Date Received
- February 21, 2008
- Decision Date
- June 22, 2009
- 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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