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FDA 510(k) Application Details - K140426
Device Classification Name
More FDA Info for this Device
510(K) Number
K140426
Device Name
ANTHRACIS REAL-TIME PCR ASSAY
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
1600 CLIFTON RD. NE, MS-C18
ATLANTA, GA 30333 US
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Contact
HYE-JOO KIM
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
NHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/19/2014
Decision Date
05/22/2014
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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