FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAS CEA (S) ASSAY
K Number: K080194
·
Decision Oct 9, 2008
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
251
Review Days
258
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Basic Information
- Device Name
- VIDAS CEA (S) ASSAY
- K Number
- K080194
- 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
- January 25, 2008
- Decision Date
- October 9, 2008
- Product Code
- DHX
- 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 |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | FDA class 2 | Immunology |
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