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FDA 510(k) Application Details - K220607
Device Classification Name
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510(K) Number
K220607
Device Name
BD MAX Enteric Viral 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
PCH
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Date Received
03/02/2022
Decision Date
09/21/2022
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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