NeuMoDx GBS Assay— 510(k) K173725

Substantially Equivalent

Neumodx Molecular, Inc.

FDA 510(k) clearance K173725 for NeuMoDx GBS Assay, Substantially Equivalent on 2018-06-26. Applicant: Neumodx Molecular, Inc.. Device class: 1.

Clearance details

Applicant: Neumodx Molecular, Inc.
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2017-12-05
Decision date: 2018-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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