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FDA 510(k) Application Details - K181427
Device Classification Name
More FDA Info for this Device
510(K) Number
K181427
Device Name
BD MAX Enteric Viral Panel, BD MAX Instrument
Applicant
Becton, Dickinson and Company
7 Loveton Circle
Sparks, MD 21152 US
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Contact
Laura Stewart
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Regulation Number
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Classification Product Code
PCH
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Date Received
06/01/2018
Decision Date
11/29/2018
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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