FDA 510(k) Application Details - K243725

Device Classification Name

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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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