510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121399Substantially Equivalent

Luminex Flexmap 3D Instrument System, Luminex Xponent 4.0 Spi Software, Flexmap 3D IVD Calibration Kit, Flexmap 3D IVD P

Luminex Corporation, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K121399 is the FDA 510(k) clearance record for LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P, a class II device, cleared for Luminex Corp. on under FDA product code NSU (Instrumentation For Clinical Multiplex Test Systems). FDA's definition for product code NSU reads: "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...". FDA records list 34 510(k) clearances for Luminex Corp., from to . As of , FDA records show no recalls naming K121399.

Clearance record

Decision date
Received
(245 days to decision)
Product code
NSU Instrumentation For Clinical Multiplex Test Systems
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Luminex Corp. 12212 Technology Blvd., Austin TX
510(k) summary
Statement
Third party review
No

Clearances, product code NSU

Trailing 12 months

FDA records hold no clearances under product code NSU in the trailing twelve months.

FDA records show no clearances under product code NSU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NSU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260