FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILLUMINA BEADXPRESS SYSTEM
K Number: K093128
·
Decision Apr 28, 2010
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
12
Applicant Total
6
Review Days
208
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Basic Information
- Device Name
- ILLUMINA BEADXPRESS SYSTEM
- K Number
- K093128
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Illumina, Inc.
- Date Received
- October 2, 2009
- Decision Date
- April 28, 2010
- Product Code
- NSU
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | FDA class 2 | Clinical Chemistry |
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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 |
| K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | Apr 28, 2010 | Substantially Equivalent |