FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
K Number: K121399
·
Decision Jan 9, 2013
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
12
Applicant Total
3
Review Days
245
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Basic Information
- Device Name
- LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
- K Number
- K121399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Luminex Corp.
- Date Received
- May 9, 2012
- Decision Date
- January 9, 2013
- Product Code
- NSU
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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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