FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
OLYMPUS AFP - ALPHA-FETOPROTEIN
K Number: K081709
·
Decision Mar 16, 2009
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
3
Review Days
272
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OLYMPUS AFP - ALPHA-FETOPROTEIN
- K Number
- K081709
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus Life Science Research Europa GmbH (Europa)
- Date Received
- June 17, 2008
- Decision Date
- March 16, 2009
- 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.
Elecsys AFP
FDA 510(k)
FDA Class 2
·Immunology
VITROS AFP
FDA 510(k)
FDA Class 2
·Immunology
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
FDA 510(k)
FDA Class 2
·Immunology
VIDAS AFP ASSAY
FDA 510(k)
FDA Class 2
·Immunology
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