FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
K Number: K093974
·
Decision Apr 22, 2010
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
3
Review Days
120
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Basic Information
- Device Name
- ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
- K Number
- K093974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osmetech Molecular Diagnostics
- Date Received
- December 23, 2009
- Decision Date
- April 22, 2010
- Product Code
- NPQ
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | FDA class 2 | Hematology |
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