FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
K Number: K124006
·
Decision Nov 19, 2013
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
6
Review Days
328
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Basic Information
- Device Name
- ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
- K Number
- K124006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5900
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Illumina, Inc.
- Date Received
- December 26, 2012
- Decision Date
- November 19, 2013
- Product Code
- PFR
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| PFR | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection | FDA class 2 | Immunology |
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 |
| DEN130011 | ILLUMINA MISEQDX PLATFORM | Nov 19, 2013 | Unknown |
| K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | Apr 28, 2010 | Substantially Equivalent |
| K093128 | ILLUMINA BEADXPRESS SYSTEM | Apr 28, 2010 | Substantially Equivalent |