Flexmap 3D
FDA 510(k) K133302 · Luminex Corp.
510(k) numberK133302
Submission
- Device name
- Flexmap 3D
- Applicant
- Luminex Corp.
Austin, TX, US - Received
- October 25, 2013
- Decision date
- January 10, 2014
- 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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Questions and answers
When was Flexmap 3D cleared by the FDA?
Flexmap 3D (K133302) received a 510(k) decision of Substantially Equivalent on January 10, 2014, 77 days after the submission was received.
What is the product code of K133302?
The FDA product code is NSU – Instrumentation For Clinical Multiplex Test Systems, a Class II (moderate risk) device regulated under 21 CFR 862.2570.