510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163636Substantially Equivalent

ePlex Respiratory Pathogen Panel

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

K163636 is the FDA 510(k) clearance record for ePlex Respiratory Pathogen Panel, a class II device, cleared for Genmark Diagnostics, Incorporated on under FDA product code OCC (Respiratory Virus Panel Nucleic Acid Assay System). FDA's definition for product code OCC reads: "A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The...". FDA records list 7 510(k) clearances for Genmark Diagnostics, Incorporated, from to . As of , FDA records show no recalls naming K163636.

Clearance record

Decision date
Received
(169 days to decision)
Product code
OCC Respiratory Virus Panel Nucleic Acid Assay System
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Genmark Diagnostics, Incorporated 5964 La Pl. Ct., Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCC

Trailing 12 months
2 clearances under product code OCC in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OCC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260