cobas eplex respiratory pathogen panel 3— 510(k) K262938

Name: FDA 510(k) clearance K262938
Creator: U.S. Food and Drug Administration
Published: 2026-10-30

Substantially Equivalent

GenMark Diagnostics, Inc.

FDA 510(k) clearance K262938 for cobas eplex respiratory pathogen panel 3, Substantially Equivalent on 2026-10-30. Applicant: GenMark Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: GenMark Diagnostics, Inc.
Product code: Product code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2026-08-21
Decision date: 2026-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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