K230267

Substantially Equivalent

NeuMoDx CT/NG Assay 2.0

Applicant: Neumodx Molecular, Inc.
Product code: QEP
Advisory panel: Microbiology
Date received: 2023-01-31
Decision date: 2023-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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