510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073506Substantially Equivalent

Luminex Lx 100/200 Instrument

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

K073506 is the FDA 510(k) clearance record for LUMINEX LX 100/200 INSTRUMENT, 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 K073506.

Clearance record

Decision date
Received
(85 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. 439 University Ave. Suite, Toronto, CA
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