FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
K Number: K093129
·
Decision Apr 28, 2010
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
6
Review Days
208
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
- ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II
- K Number
- K093129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Illumina, Inc.
- Date Received
- October 2, 2009
- Decision Date
- April 28, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NPQ), ordered by most recent decision date.
INVADER FACTOR V
FDA 510(k)
FDA Class 2
·Hematology
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
FDA 510(k)
FDA Class 2
·Hematology
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
FDA 510(k)
FDA Class 2
·Hematology
INFINITI SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
FACTOR V LEIDEN KIT
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Illumina, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132750 | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY | Nov 19, 2013 | Substantially Equivalent |
| DEN130042 | MISEQDX UNIVERSAL KIT 1.0 | Nov 19, 2013 | Unknown |
| K124006 | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY | Nov 19, 2013 | Substantially Equivalent |
| DEN130011 | ILLUMINA MISEQDX PLATFORM | Nov 19, 2013 | Unknown |
| K093128 | ILLUMINA BEADXPRESS SYSTEM | Apr 28, 2010 | Substantially Equivalent |