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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 Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
510(k) Number K230267
Device Name NeuMoDx CT/NG Assay 2.0
Applicant
Neumodx Molecular, Inc.
1250 Eisenhower Place
Ann Arbor,  MI  48108
Applicant Contact Eveline Arnold
Correspondent
Qiagen
19300 Germantown Rd.
Gernmantown,  MD  20874
Correspondent Contact Eveline Arnold
Classification Product Code
QEP  
Date Received01/31/2023
Decision Date 12/22/2023
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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