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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microbial Nucleic Acid Storage And Stabilization Device
510(k) Number K212113
Device Name MagXtract Collection Tube
Applicant
Magbio Genomics, Inc.
944 Clopper Rd.
Gaithersburg,  MD  20878
Applicant Contact Mothomang Mlalazi-Oyinloye
Correspondent
Brij Strategic Consultations, LLC
20271 Goldenrod Ln.
Suite 2020
Germantown,  MD  20876
Correspondent Contact Mukesh Kumar
Classification Product Code
QBD  
Date Received07/07/2021
Decision Date 07/28/2022
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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