FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
MISEQDX UNIVERSAL KIT 1.0
K Number: DEN130042
·
Decision Nov 19, 2013
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
0
Applicant Total
6
Review Days
46
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Basic Information
- Device Name
- MISEQDX UNIVERSAL KIT 1.0
- K Number
- DEN130042
- Device Class
- FDA class 1
- Clearance Type
- Direct
- Regulation Number
- 862.3800
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- Illumina, Inc.
- Date Received
- October 4, 2013
- Decision Date
- November 19, 2013
- Product Code
- PFT
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| PFT | Reagents For Molecular Diagnostic Test Systems | FDA class 1 | Clinical Chemistry |
Other Clearances by Illumina, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132750 | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY | Nov 19, 2013 | Substantially Equivalent |
| K124006 | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY | Nov 19, 2013 | Substantially Equivalent |
| 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 |