FDA Cleared
New Device
Pathway: 510K
cobas eplex respiratory pathogen panel 3
Applicant:
GenMark Diagnostics, Inc.
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
QOF
Review Panel:
Microbiology
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-08-21
Decision Date:
2026-10-30
Total Review Duration:
70 calendar days (70 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Alyssa Agana
Role: SUBMITTER_CONTACT
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