LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P— 510(k) K121399

Name: FDA 510(k) clearance K121399
Creator: U.S. Food and Drug Administration
Published: 2013-01-09

Substantially Equivalent

Luminex Corp.

FDA 510(k) clearance K121399 for LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P, Substantially Equivalent on 2013-01-09. Applicant: Luminex Corp.. Device class: 2.

Clearance details

Applicant: Luminex Corp.
Product code: Code NSU
Device class: Class 2
Regulation: 21 CFR 862.2570
Advisory panel: Clinical Chemistry
Date received: 2012-05-09
Decision date: 2013-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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