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FDA 510(k) Application Details - K152523
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
More FDA Info for this Device
510(K) Number
K152523
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY
1430 VETERANS DRIVE
FORT DETRICK, MD 21702-9232 US
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Contact
ROBERT E MILLER
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Regulation Number
866.3980
More FDA Info for this Regulation Number
Classification Product Code
OCC
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More FDA Info for this Product Code
Date Received
09/03/2015
Decision Date
10/01/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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