510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163652Substantially Equivalent

ePlex Instrument

Genmark Diagnostics, Incorporated, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163652 is the FDA 510(k) clearance record for ePlex Instrument, a class II device, cleared for Genmark Diagnostics, Incorporated 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 7 510(k) clearances for Genmark Diagnostics, Incorporated, from to . As of , FDA records show no recalls naming K163652.

Clearance record

Decision date
Received
(168 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
Genmark Diagnostics, Incorporated 5964 La Pl. Ct., Carlsbad CA
510(k) summary
Summary PDF
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