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FDA 510(k) Application Details - K132508
Device Classification Name
More FDA Info for this Device
510(K) Number
K132508
Device Name
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
Applicant
CENTERS FOR DISEASE CONTROL AND PREVENTION
1600 CLIFTON RD., N.E.
MAILSTOP C-18
ATLANTA, GA 30333 US
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Contact
HYE-JOO KIM, PHARM.D.
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Regulation Number
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Classification Product Code
OZE
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Date Received
08/12/2013
Decision Date
09/23/2013
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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