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FDA 510(k) Application Details - K183462
Device Classification Name
More FDA Info for this Device
510(K) Number
K183462
Device Name
Applied Biosystems Bacillus anthracis Detection Kit
Applicant
MRIGlobal
425 Volker Boulevard
Kansas City, MO 64110 US
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Contact
Fran White
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QIF
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More FDA Info for this Product Code
Date Received
12/14/2018
Decision Date
10/01/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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