Luminex Flexmap 3D Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3D IVD Calibration Kit, Flexmap 3D IVD P
FDA 510(k) K121399 · Luminex Corp.
Submission
- Device name
- Luminex Flexmap 3D Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3D IVD Calibration Kit, Flexmap 3D IVD P
- Applicant
- Luminex Corp.
Austin, TX, US - Received
- May 9, 2012
- Decision date
- January 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NSU – Instrumentation For Clinical Multiplex Test Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2570
- Specialty
- Clinical Chemistry
Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing…
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| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX · Traditional | 10/30/2017SE |
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Questions and answers
When was Luminex Flexmap 3D Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3D IVD Calibration Kit, Flexmap 3D IVD P cleared by the FDA?
Luminex Flexmap 3D Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3D IVD Calibration Kit, Flexmap 3D IVD P (K121399) received a 510(k) decision of Substantially Equivalent on January 9, 2013, 245 days after the submission was received.
What is the product code of K121399?
The FDA product code is NSU – Instrumentation For Clinical Multiplex Test Systems, a Class II (moderate risk) device regulated under 21 CFR 862.2570.