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FDA 510(k) Application Details - K181711
Device Classification Name
More FDA Info for this Device
510(K) Number
K181711
Device Name
BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
Applicant
Microbiologics, Inc.
200 Cooper Avenue North
St. Cloud, MN 56303 US
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Contact
Tina Sobania
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Regulation Number
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Classification Product Code
PMN
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More FDA Info for this Product Code
Date Received
06/28/2018
Decision Date
08/15/2018
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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