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FDA 510(k) Application Details - K201017
Device Classification Name
More FDA Info for this Device
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 G1P4S5 CA
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Contact
Katie Edwards
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Regulation Number
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Classification Product Code
PQA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2020
Decision Date
10/18/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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