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FDA 510(k) Application Details - K192485
Device Classification Name
Respiratory Virus Panel Nucleic Acid Assay System
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510(K) Number
K192485
Device Name
Respiratory Virus Panel Nucleic Acid Assay System
Applicant
Applied BioCode, Inc.
10020 Pioneer Blvd Suite 102
Santa Fe Springs, CA 90670 US
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Contact
Robert Di Tullio
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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
09/10/2019
Decision Date
12/23/2019
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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