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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
510(k) Number K262938
Device Name cobas eplex respiratory pathogen panel 3
Applicant
GenMark Diagnostics, Inc.
5964 La Pl. Ct.
Carlsbad,  CA  92008
Applicant Contact Alyssa Agana
Correspondent
GenMark Diagnostics, Inc.
5964 La Pl. Ct.
Carlsbad,  CA  92008
Correspondent Contact Alyssa Agana
Regulation Number866.3981
Classification Product Code
QOF  
Date Received08/21/2026
Decision Date 10/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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