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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nucleic acid amplification assay system, group b streptococcus, direct specimen test
510(k) Number K173725
Device Name NeuMoDx GBS Assay
NeuMoDx Molecular, Inc.
1250 Eisenhower Place
Ann Arbor,  MI  48108
Applicant Contact Kay Fuller
Medical Device Regulatory Solutions, LLC
230 Collingwood Dr.
Suite 260
Ann Arbor,  MI  48103
Correspondent Contact Kay Fuller
Regulation Number866.3740
Classification Product Code
Subsequent Product Code
Date Received12/05/2017
Decision Date 06/26/2018
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