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FDA 510(k) Application Details - K131930
Device Classification Name
More FDA Info for this Device
510(K) Number
K131930
Device Name
JBAIDS ANTHRAX DETECTION KIT
Applicant
BIOFIRE DIAGNOSTICS, INC.
390 Wakara Way
Salt Lake City, UT 84108 US
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Contact
CYNTHIA PHILLIPS
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Regulation Number
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Classification Product Code
NHT
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More FDA Info for this Product Code
Date Received
06/27/2013
Decision Date
08/05/2013
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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