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FDA 510(k) Application Details - K243725
Device Classification Name
More FDA Info for this Device
510(K) Number
K243725
Device Name
BD Vaginal Panel
Applicant
Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152 US
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Contact
Joseph Basore
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Regulation Number
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Classification Product Code
PQA
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Date Received
12/03/2024
Decision Date
12/19/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K243725
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