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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
510(k) Number K201017
Device Name BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
Applicant
GeneOhm Sciences Canada, Inc. (BD Life Sciences)
2555 Boul. Du Parc-Technologique
Quebec,  CA G1P4S5
Applicant Contact Katie Edwards
Correspondent
GeneOhm Sciences Canada, Inc. (BD Life Sciences)
2555 Boul. Du Parc-Technologique
Quebec,  CA G1P4S5
Correspondent Contact Susan Werner
Classification Product Code
PQA  
Date Received04/17/2020
Decision Date 10/18/2021
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
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