FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIDAS AFP ASSAY
K Number: K080017
·
Decision Sep 26, 2008
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
251
Review Days
267
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Basic Information
- Device Name
- VIDAS AFP ASSAY
- K Number
- K080017
- 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 3, 2008
- Decision Date
- September 26, 2008
- Product Code
- LOJ
- 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 |
|---|---|---|---|
| LOJ | Kit, Test,Alpha-Fetoprotein For Testicular Cancer | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOJ), ordered by most recent decision date.
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OLYMPUS AFP - ALPHA-FETOPROTEIN
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DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
FDA 510(k)
FDA Class 2
·Immunology
ST AIA-PACK AFP ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
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