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FDA 510(k) Application Details - K152408
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
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510(K) Number
K152408
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
FOCUS DIAGNOSTICS, INC.
11331 VALLEY VIEW STREET
CYPRESS, CA 90630 US
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Contact
IRENE M GUZMAN
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Regulation Number
866.3980
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Classification Product Code
OCC
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More FDA Info for this Product Code
Date Received
08/25/2015
Decision Date
09/21/2015
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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